bluuebunny/crossref_metadata_2025 huggingface dataset:
386 An Exploratory Study of Bedtime Procrastination and Emotional Regulation Strategies in Insomnia compared to healthy individuals
Authors: Kim Goeun , Nam Hyojin , Jeon Huisu , Suh Sooyeon
Published: May 2021

Introduction

Bedtime Procrastination (BP) is defined as the behavior of voluntarily delaying going to bed, without having external reasons for doing so. Recent research on procrastination behavior suggests that when negative emotions are elevated, procrastination behaviors can be triggered in order to find pleasure to avoid and alleviate them. Procrastination can also occur when there is difficulty regulating emotions. In addition, the reason for bedtime procrastination may be different depending on whether the individuals present with insomnia. According to previous studies, patients with insomnia may exhibit more pronounced negative avoidance of bedtime due to prolonged sleeplessness. Therefore, this study compared the difference between of the bedtime procrastination and the emotional regulation strategies between the insomnia group and the healthy group.

Methods

This study was conducted in 582 adults (mean age 23.06 ±2.16 years), 81.6% females. Individuals scoring higher than 15 on the Insomnia Severity Index (ISI) were classified into the insomnia group (n=375), and those less than 15 were classified into the healthy group (n=207). Participants completed the Bedtime Procrastination Scale (BPS), Emotional Regulation Strategies Checklist. Data was analyzed using descriptive statistics, chi square test, and independent t tests.

Results

The insomnia group had significantly higher bedtime procrastination scores than the healthy group (t=-6.241, p<.001), and also the avoidant/distractive regulation style score was significantly higher (t=-1.969, p<.05). In addition, the score of active regulation style was significantly lower in the insomnia group than in the healthy group (t=3.050, p<.01). There was no significant difference between the two groups in the support-seeking regulation style.

Conclusion

Based on these results, it was confirmed that there was a difference in the bedtime procrastination and the emotional regulation strategies between the insomnia group and the healthy group.

Support (if any)

This work was supported by the Ministry of Education of the Republic of Korea and the National Research Foundation of Korea(NRF-2018S1A5A8026807)
388 Familial natural short sleepers have greater resilience than unaffected family members
Authors: Ashbrook Liza , Krystal Andrew , Fu Ying-Hui , Ptáček Louis
Published: May 2021

Introduction

Resilience, a life-long trait, corresponds to the ability to bounce back from adversity. What factors influence resilience is unclear. Here we describe a cohort of individuals with familial natural short sleep (FNSS). Four genes in five families have been identified that confer this trait, DEC2, NPSR1, GRM1 and ADRB1. Individuals in this cohort share a resilience phenotype alongside this decreased sleep need.

Methods

Those reporting less than 6.5 hours of sleep when allowed to sleep ad libitum without any complaints regarding overnight sleep or daytime sleepiness were then interviewed to determine FNSS affected status from 2009 to 2020. Data on mood, depression, sleepiness and resilience were collected from participants and family members enrolled in the FNSS study.

Results

163 individuals meeting criteria for FNSS were enrolled. Compared to 47 unaffected family members, they had significantly shorter sleep duration as measured by self report and actigraphy, significantly more resilience as measured by the Connor-Davidson Resilience Scale, significantly less sleepiness as measured by the Epworth Sleepiness Scale, and significantly fewer symptoms of depression as measured by the Beck Depression Inventory.

Conclusion

FNSS individuals appear to have a distinct phenotype including shorter sleep duration, greater resilience, less subjective sleepiness, and fewer symptoms of depression. Better understanding the genetics and characteristics of those with familial natural short sleep may provide insight into mechanisms of both restorative sleep and resilience.

Support (if any)

This work was supported by NIH grants NS099333, NS072360 and NS104782 to L.J.P. and Y-H.F., and by the William Bowes Neurogenetics Fund to L.J.P. and Y.H.F.
392 Effect of Obstructive Sleep Apnea Severity, Sleep Stage and Position on Patterns of Oximetric Desaturations and Resaturations
Authors: Thanaviratananich Sikawat , Cheng Hao , Pino Maria , Sundar Krishna
Published: May 2021

Introduction

Obstructive sleep apnea (OSA) severity based upon the apnea-hypopnea index (AHI) ignores many characteristics such as the duration of apnea-hypopneas, the duration and degree of oxygen desaturations (SpO2) etc. While hypoxemic burden has received increased attention given its relationship with cardiovascular outcomes, the role of oximetric resaturation vs. desaturation times is not understood. Resaturation times tend to be constant in contrast to desaturation durations. This study was done to assess desaturation and resaturation indices in patients with different OSA severity in differing sleep stages and positions.

Methods

Oximetric desaturation and resaturation slopes were calculated in patients with different OSA severities as rate of change in oxygen saturations (ΔSpO2/Δtime).

Results

33 patients with OSA were studied (11 in each OSA severity group). Mean desaturation duration was 20.12 ±1.10 seconds with shorter NREM desaturation times (mean 19.07 ±1.11 seconds) as compared to REM desaturation durations (mean 26.66 ±2.69 seconds) (p-value 0.009). Non-supine and supine mean desaturation durations were similar (19.59 ±1.77 and 18.73 ±1.18 seconds respectively). Mean resaturation durations were shorter than desaturation durations at 12.46 ±0.84 seconds and was significantly lower in NREM sleep than in REM sleep (9.32 ±0.41 seconds vs 12.50 ±0.75 seconds p-value 0.002). Resaturation slopes (0.44 %/second (±0.028 %/second)) were steeper as compared to desaturation slopes (-0.26 %/second (±0.02 %/second)) without significant difference between NREM vs. REM desaturation or resaturation slopes. While desaturation slopes were not affected by sleep position, resaturation slopes were significantly steeper in supine compared to non-supine sleep (p-value 0.0046). Desaturation durations increased with OSA severity, but resaturation times decreased (resaturation slopes became steeper) with significant differences between patients with different OSA severity.

Conclusion

This study demonstrated that oxygen resaturation slopes varied according to different OSA severity and sleep position. Given that faster resaturation rates may reflect the possibility of higher degrees of reoxygenation-related oxidative stress, this should be assessed as a novel index to predicate OSA outcomes.

Support (if any):
401 Clinical Phenotypes of Obstructive Sleep Apnea in World Trade Center Responders
Authors: Parekh Ankit , Castillo Bresne , Kim Do Hyung , Black Kathleen , de la Hoz Rafael , Rapoport David , Sunderram Jag , Ayappa Indu
Published: May 2021

Introduction

The heterogeneity of symptoms in obstructive sleep apnea (OSA) patients has been recently formalized into 3 distinct clusters: Sleepy, Disturbed Sleep, and Minimally Symptomatic. Our previous data showed that OSA is highly prevalent (>75%) in World Trade Center (WTC) responders, and positive airway pressure (PAP) treatment adherence is very poor (<20%). To better understand the heterogeneity of OSA in the WTC cohort, here we sought to examine the distribution of these distinct clinical phenotypes.

Methods

643 subjects with no history of OSA or reported loud and frequent snoring before 9/11/2001 from the WTC health program clinical centers at Rutgers RWJMS, New Jersey, NYU School of Medicine, and Icahn School Medicine at Mount Sinai, New York underwent 2 nights of home sleep testing using the ARES unicorder (SleepMed, Inc., West Palm Beach, FL, USA). Epworth Sleepiness Scale (ESS), sleep onset insomnia, and sleep maintenance insomnia were assessed with questionnaires. OSA was defined as (AHI4%>=5 or RDI>=15/hr). The three clusters were defined as 1) Sleepy (ESS>10 and/or sleep onset/maintenance insomnia); 2) Disturbed Sleep (not sleepy (ESS<=10) and sleep onset/maintenance insomnia); and 3) Minimally Symptomatic (not sleepy (ESS<=10) and no sleep onset/maintenance insomnia). Distribution of clusters in the WTC cohort was compared to published data from the Sleep Apnea Global Interdisciplinary Consortium (SAGIC) and the Hispanic Community Health Study/Study of Latinos (HCHS/SOL).

Results

Among the subjects diagnosed with OSA (N 440; AHI4%=13(15); RDI =28(19); median(iqr); 81% men; age, 33–87 years; BMI, 27.4±3.7 kg/m2), the distribution of clinical phenotypes was 31.4% sleepy, 48.9% disturbed sleep, and 19.7% minimally symptomatic, and did not differ between OSA severity groups. In comparison to SAGIC and HCHS/SOL, the WTC cohort exhibited significantly increased prevalence of the disturbed sleep phenotype (WTC vs SAGIC: 48.9% vs. 19.8%, □2=54.9; p<0.001; WTC vs. HCHS/SOL: 48.9% vs. 38.1%, □2=26.1, p<0.001).

Conclusion

The predominant clinical phenotype of OSA in the WTC cohort is disturbed sleep (insomnia) and its prevalence is significantly greater than what has been observed in other large OSA cohorts. These findings may help explain the poor adherence to PAP treatment observed in the WTC cohort.

Support (if any)

NIOSH U01OH01415; AASM Foundation 233-BS-20.
405 The Effect of a Patient Survey in the Evaluation of Obstructive Sleep Apnea in a High Risk Cardiology Outpatient Population
Authors: Patel Dev , Patel Ishan , Cohen Marc , Patel Sunil
Published: May 2021

Introduction

Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder. The estimated prevalence is approximately 15 to 30 percent in males and 10 to 15 percent in females. Patients with OSA have an increased propensity for cardiovascular diseases and obesity. Observational studies have demonstrated a consistent association between OSA and hypertension, coronary artery disease, cardiac arrhythmias, and heart failure. The purpose of this study is to evaluate if a patient survey can improve the diagnosis of OSA in a high-risk outpatient cardiac clinic.

Methods

In an outpatient cardiac clinic, a retrospective analysis of OSA evaluations was done before and after the use of patient surveys in a high-risk population. The high-risk patient group was defined by the presence of two or more of the following conditions: hypertension, heart failure, cardiac arrhythmias, atrial fibrillation, obesity with a BMI of 30 or more, coronary artery disease, diabetes mellitus, chronic lung disease, history of cerebrovascular accident (CVA), hypothyroidism and chronic renal insufficiency. The patient survey included questions on the presence of daytime sleepiness, presence of snoring, ESS score, choking in sleep, witness apnea, and frequent waking in sleep.

Results

During the four months of patient survey use, a total of 143 patients were evaluated as compared to 86 patients in the prior four months without the use of the survey. A significant increase (66.3%) of OSA evaluations was observed during the patient survey period.

Conclusion

The use of patient surveys showed a significant improvement in OSA diagnoses in the defined high-risk patient group. Patient surveys might be beneficial to improve the under diagnosis of sleep apnea in high-risk patient populations. Additional research needs to be done to establish the impact of such intervention on patient outcomes.

Support (if any):
410 Sleep and Stroke: Improved OSA Time to Diagnosis for Stroke Patients Using an Inpatient Diagnostic and Treatment Strategy
Authors: Naik Sree , Zand Ramin , El Andary Nada , Morse Anne Marie
Published: May 2021

Introduction

Obstructive sleep apnea (OSA) is an independent risk for development of stroke. Despite this known relationship there is insufficient screening of sleep apnea in many recognized stroke centers, including Geisinger. In 2016, 68 patients were admitted to Geisinger Wyoming Valley (GWV) with ischemic stroke. Less than 10% had a Sleep Medicine Referral. When referred, average time to CPAP initiation was 9–12 months. An ongoing quality improvement (QI) study implemented inpatient home sleep apnea testing (HSAT) for stroke patients and subsequent autoPAP, if positive. Interim analysis demonstrates high rates of OSA using this screening method, suggesting a viable mechanism for improved time to OSA diagnosis.

Methods

All patients at GWV evaluated by neurology due to acute neurologic change were considered for enrollment (9/1/2019-10/10/2020). Only patients 18 years and older hospitalized with diagnosis of ischemic stroke were included. Patients were consented for participation. The evening of enrollment an Alice NightOne HSAT device was applied by a respiratory technician. If OSA was identified, the patient was placed on APAP the following evening.

Results

A total of 302 patients were screened with 82 patients meeting criteria for enrollment (27%) and 64 consenting for participation and attempting HSAT (21%). 18 of the 82 (22%) eligible patients refused participation. 12 patients (19%) had insufficient HSAT studies to determine OSA diagnosis. Of the patients who successfully completed an adequate HSAT study 85% (44/52) had OSA identified.

Conclusion

OSA is highly prevalent in patients with ischemic stroke and represents a modifiable risk factor for recurrent stroke. At baseline, rate of and time to diagnosis of OSA was poor with less than 10% of stroke patients receiving a sleep referral and time to initiation of CPAP was approximately 1 year. Standard universal in hospital surveillance for OSA using an HSAT in admitted stroke patients appears to allow for an increased rate of capture, but perhaps also a shorter time to diagnosis. This data may also suggest that prevalence of OSA in this stroke population is similar to slightly higher than previously reported. Further analysis of this program is required to evaluate for statistical significance and impact of APAP use.

Support (if any)

Geisinger Health Plan
411 REM predominance of OSA: Associated with supine position, but not with CPAP adherence
Authors: Schecter Scott , Liu Junjie
Published: May 2021

Introduction

Obstructive sleep apnea (OSA) is a heterogeneous disease dependent on many factors including the sleep stage and the body position. OSA is often more severe during the rapid eye movement (REM) sleep stage, a phenomenon known as REM predominance. Prior studies suggested associations of higher REM predominance of OSA with younger age, higher obesity, and lower adherence to continuous positive airway pressure (CPAP) therapy, but these studies had small cohort sizes. Here we leverage home-based sleep tests (HST) that estimate REM sleep and measure body position to study REM predominance in a larger cohort of OSA patients.

Methods

We retrospectively reviewed patients who took HST at our clinic using devices based on peripheral arterial tonometry (WatchPAT, Itamar Medical). The HST results included estimated REM sleep periods and measured body positions. Auto-titrating CPAP therapy was prescribed for the majority of OSA patients diagnosed by the HST. Our inclusion criteria were: apnea-hypopnea index (AHI) above 5 /hour, estimated REM sleep time above 30 minutes, oxygen saturation below 90% (T90) for less than 10 minutes, and successful retrieval of CPAP usage data. CPAP adherence was defined as the percentage of nights with CPAP usage above four hours, and REM predominance as the ratio between REM AHI and non-REM AHI. Additionally, the percentage of estimated sleep time in supine position was calculated.

Results

Among 292 consecutive patients whose HST were reviewed, 113 patients met the inclusion criteria. The 25th-75th percentile ranges of age, body mass index (BMI), AHI, REM predominance, CPAP adherence and supine sleep percentage were 36–56 years, 28.1–38.4 kg/m2, 8.9–25.9 /hour, 1.27–2.89, 40%-97% and 28%-72%, respectively. REM predominance was not associated with CPAP adherence (P > 0.05), but was significantly associated with lower age, higher BMI, and higher supine sleep percentage (all P < 0.01).

Conclusion

We found that REM-predominant OSA is relatively more prevalent not only in young and obese patients, but in patients who sleep relatively more in the supine position. This association of REM predominance with body position is a novel finding to our knowledge. Contrary to prior studies, we did not find association of REM predominance with adherence to CPAP therapy.

Support (if any):
413 Inpatient Sleep Screens: Effective for Screening but Poor Follow Up
Authors: Chawla Upneet , Chadha Avneet , Martin Abigail , Culnan Elizabeth , Kirkpatrick Aaron , Arantes Henry , Lastra Alejandra
Published: May 2021

Introduction

Only 20% of adult Americans with Obstructive Sleep Apnea (OSA) are thought to have been diagnosed. Portable monitors (PM) can provide shorter time to diagnosis and treatment in at risk populations including inpatients. Data on inpatient sleep screen testing outcomes and population phenotypes are limited. We hypothesized that inpatients undergoing sleep screens via PM have higher disease severity but are less adherent to follow up.

Methods

We conducted a retrospective observational study comparing severity of OSA based on apnea-hypopnea index (AHI) and compliance with follow up between patients who received inpatient vs. outpatient sleep screens. There was a total of 347 patients, 18 years and older, who received a sleep screen from August 2017 to August 2018. Exclusion criteria were cancellations/no shows (13.56% inpatients vs. 13.51% outpatients) or loss of data (26.12% inpatients vs. 23.72% outpatients). For analysis, t-test and chi-square were used for continuous and categorical variables respectively.

Results

The patients diagnosed with severe OSA were more than double in the inpatient group vs. the outpatient group, 46.7% and 21.7% respectively. The inpatient group had a higher average AHI (30/h) compared to the outpatient group (20.3/h). 30.7% of the inpatient group were adherent with their follow up vs. 83.3% of the outpatient group. A chi-square test of independence demonstrated a significant difference between testing location and follow up (p < .001). Those in the inpatient group were significantly older (mean 60.4 years old) than the outpatient group (47.5 years old). There was no significant difference in gender between the groups. The inpatient group had significantly higher average body mass index (39.9 kg/m2) when compared to the outpatient group (34.3 kg/m2).

Conclusion

Hospitalized patients screened for OSA with portable monitors are significantly more likely to have severe disease when compared to outpatients. Despite this, adherence to follow up is poor. Systematic evaluation of inpatient OSA screening program effectiveness and factors impacting adherence to follow up and treatment are needed.

Support (if any):
425 Investigating the Utility of Routine Carbon Dioxide Measurements During Polysomnography in the Evaluation of Obese Adult Patients
Authors: Nuzhny Valentin , Majid Ruckshanda , Imtiaz Komal , Mathew Reeba
Published: May 2021

Introduction

With the increasing prevalence of obesity, the diagnosis of obstructive sleep apnea (OSA) and obesity hypoventilation syndrome (OHS) have also increased. Adding routine transcutaneous carbon dioxide (TcCO2) or end-tidal carbon dioxide sensors (EtCO2) may add beneficial information to the polysomnogram (PSG) and expand the diagnostic and treatment capabilities in this population. Our study looks at the use of this parameter in obese adults on whom CO2monitoring has been used.

Methods

We performed a retrospective chart review of obese adult patients (body mass index [BMI] >30) undergoing a PSG. We documented the EtCO2 values at baseline (supine awake) and during sleep. Correlations between the EtCO2 readings and BMI were reviewed. We excluded patients that had poor EtCO2 waveforms and patients with known preexisting hypoventilation syndromes, such a COPD.

Results

Fifty patients were identified between January and November 2020 at the Memorial Hermann Sleep Center. 54% were female and 46% were male with an average age of 55.3 years (range 26–73) and an average BMI for the cohort of 40.1 (SD +/-9.5). The average AHI on the diagnostic study (CMS criteria) was 30.9 events/hour (SD +/- 43) and the average oxygen desaturation nadir was 79%. Sixteen patients (32%) met diagnostic criteria for OHS based on the baseline awake EtCO2 which would have otherwise been missed without CO2 monitoring. When comparing the mean values of the ETCO2 between Group 1 whose BMI was less than 40 kg/m2 (39.9 mmHg) to Group 2 whose BMI was greater than 40 kg/m2 (45.9 mm Hg), the difference was statistically significant with a p-value is 0.001.

Conclusion

OHS is reported to have greater mortality when compared to OSA. CO2 monitoring is currently only routinely required in pediatric PSGs. Our review suggests a higher diagnostic yield of OHS in adults with the use of CO2 monitoring especially when morbidly obese. Given the alarming trend towards obesity in the US, this advocates for the routine use of CO2 monitoring in adult obese patients. Although more research is needed, we may draw a conclusion that there is meaningful data to support the use of routine ETCO2 monitoring in this adult patient population.

Support (if any):
429 What are Patient Characteristics, Nursing Interventions and Patient Outcomes for Patients with Difficulty Adapting to CPAP?
Authors: Letourneau Marie , Dallaire Julie , Drummond Nicole , Gomes Nayomi , Parsons Marc , Benedetti Andrea , Kimoff Richard , Laizner Andrea
Published: May 2021

Introduction

A sleep nurse clinician was added to our care team to provide situationally responsive educational, behavioral and troubleshooting interventions and case management to patients identified as high risk for untreated SDB. The objective of this study was to describe the patient characteristics, nursing interventions, and impact on CPAP usage among patients referred to the nurse-clinician.

Methods

Descriptive exploratory retrospective chart review was used to identify patient characteristics for all new patients referred; in-depth extraction was conducted for patients who had home CPAP for ≥ 1 month and experienced difficulty using CPAP. We examined: issues using CPAP, frequency and types of nursing contacts, nursing interventions and CPAP usage. Patient characteristics of those with difficulty adapting to CPAP were compared to those referred for assistance to obtain CPAP. Change in objective CPAP usage before vs after sleep nurse case management was determined when possible.

Results

403 patients were referred, with mean (SD) age: 54.8 y (15.7), 56.1% men, RDI: 45.4 (31.4), 42.4% employed, 16.6% retired, 25% with ≥ 3 co-morbidities plus SDB. Difficulty adapting group (n = 204) had more women (p = 0.033), more employed (p = 0.03), and more insomnia (p = 0.001). CPAP issues included: mask (18%), ENT (14%), constraining beliefs (14%), access to treatment (12%), pressure intolerance (11%), comorbidities (11%), suboptimal usage (7%), insomnia (7%). Nursing contact: 74% subjects had ≤ 4 contacts (range: 1–16), 53% in-person, 25% telephone calls, 22% other. Nursing interventions were: educational (33%), troubleshooting (30%), behavioural (20%), liaison/coordination of care (13%), promoting self-management skills (3%). Preliminary mean CPAP usage (n = 18) improved by 40.0 (112.3) min and by 7.4 (31) % of nights used ≥ 4 hrs (p=NS; data extraction ongoing).

Conclusion

Demographic data identified women and insomnia to be significant characteristics in the difficulty adapting group. This model of care identified 2 types of interventions not previously recognized in typical interventions to promote CPAP adaptation: Liaison/coordination of care and promoting self-management skills. Some patients were able to increase their CPAP usage.

Support (if any)

MUHC Nursing Research Small Grants Award was supported by the Newton Foundation and the Montreal General Hospital Foundation.
433 Insomnia and Restless Legs Syndrome in Patients with Upper Airway Stimulation Therapy
Authors: Jomha Mohammed , Manchanda Shalini , Stahl Stephanie , Parker Noah
Published: May 2021

Introduction

Insomnia and restless legs syndrome (RLS) are common sleep disorders that may impact obstructive sleep apnea (OSA) treatment. To our knowledge, no studies have investigated whether these comorbidities affect upper airway stimulation (UAS) therapy adherence and outcomes. This study aims to explore possible effects of insomnia and RLS in patients using UAS therapy.

Methods

All patients who underwent UAS system implantation for treatment of OSA at our facility were retrospectively studied. Pre- and post-implant histories and data, including diagnostic sleep testing, otolaryngology evaluation, activation results, and treatment evaluation, were analyzed. Patients with no insomnia or RLS were compared to patients with insomnia, RLS, or both. Apnea-hypopnea index (AHI), Epworth Sleepiness Scale (ESS), and adherence were compared pre- and post-treatment for each group.

Results

Sixty-four patients who have undergone UAS implantation at our center have completed post-treatment in-lab titration and evaluation of their UAS system. Insomnia was present in 47%, RLS in 28%, and both insomnia and RLS in 14%. In all groups, the overall AHI during in-lab titration was >50% lower than the pre-treatment AHI (16.1+/-14.3/h vs 32.5+/-13.1/h, p<0.001). While the trend in AHI reductions suggested a lower AHI in those without insomnia or RLS, the reduction did not reach statistical significance (no insomnia or RLS 15.7+/-12.9/h, insomnia 16.9+/-16.7/h, RLS 19.0+/-15.5/h, both insomnia and RLS 23.4+/-18.4/h). UAS therapy usage was reduced in patients with RLS (3.9+/-2.6 h/night, p=0.029) and in patients with both insomnia and RLS (3.9+/-1.3 h/night, p=0.046) compared to patients with neither comorbidity (5.9+/-1.9 h/night). Mean reduction in ESS was similar across groups, averaging from 11+/-5 pre-treatment to 7+/-5 post-treatment (p<0.001).

Conclusion

Insomnia and RLS are common in patients using UAS therapy for OSA. Pre- and post-treatment residual AHI and ESS significantly improved in all patient groups assessed. A decrease in UAS usage was present in patients with RLS and both RLS and insomnia. Our study suggests that identification and treatment of RLS and insomnia may play an important role for UAS therapy adherence and efficacy, thus, optimizing care.

Support (if any):
440 A Multi-Center Preference study of a Novel Oral Appliance Design and Material
Authors: Murphy Mark
Published: May 2021

Introduction

AASM guidelines for OAT advise sleep medicine physicians to consider patient preference when determining the treatment modality for mild and moderate OSA. This investigation evaluates patient preference for a novel OAT device in comparison with CPAP and other legacy OAT devices.

Methods

A novel OA (ProSomnus EVOTM, Pleasanton, CA) was manufactured from digital records of U/L impressions and bite registrations. 31 Patients (all with one or more legacy OAs and 20 previous CPAP users) across 7 dentists were surveyed regarding preferences of this novel OA using a 0–10 scale. Samples were analyzed for stainability by mustard at 37C for 10 days against representative predicates using colorimetry.

Results

Patient Survey 100% Preferred the novel OA over CPAP, would wear it and easier to clean and preferred over their previous appliance This novel OA was comfortable and smaller 9.3 Easier to close my lips together 8.8 Confident in device durability/will not break 9.1 No crowns were removed/damaged Dentists Survey 81% no adjustment interventions for fit at delivery, average adjustment time was 3.1 min. 100% Would prescribe this novel OA again and recommend to colleagues This novel OA was easier to deliver than other devices 9.1 Retention was just right at delivery 8.9 Would use this novel OA on wider range of patients 9.8 This monolithic novel OA would be easy to keep clean 9.8 Stain Testing in □E from Colorimetry Milled PMMA 3.06 Milled novel OA 3.20 CPAP Mask plastic 7.54 Milled PMMA w/soft Liner/Fulcrum Strap 8.27 CPAP Mask silicone 11.60 PMMA +Liner Anterior Hook 19.05 PMMA with Liner Herbst 32.05 Nylon/Airway 90.70 Nylon/Strap 96.99

Conclusion

Patients preferred this novel OA over CPAP and all other devices similarly designed for comfortable easy fit and delivery (soft liners and printed nylon) without compromising the comfort, cleanability or strength. Liner-less milled devices outperform all other devices with less staining. Color stability from mustard was significantly better for the milled PMMA and this Novel OA materials than all other combinations

Support (if any)

None
444 Enhancing PAP Compliance Efficacy with Early Closer Follow-ups (2–3 days vs others): A Retrospective Single-Centre Review
Authors: Bandeali Almas , Khan Amir , Wyrick Brenda
Published: May 2021

Introduction

PAP is an effective gold standard for OSA treatment; however, compliance remains an issue. Centre for Medicare defines compliance as PAP usage of ≥4hrs daily and ≥70% in a 30-day period. This study aimed at evaluating the effectiveness of early patient-centred follow-ups (2–3 days mandatory versus 4 weeks mandatory and/or as needed basis).

Methods

Retrospective data analysis of 100 consecutive patients (≥18 years) over a year in an interrupted time series with pre-test (Group1) and post-test (Group2) of 50 patients each. All patients included were symptomatic (ESS ≥10), CPAP naive, diagnosed with OSA, and diagnostic AHI ≥5. All received a post diagnostic sleep questionnaire assessing their overall quality of sleep with PAP therapy. Therapeutic AHI was collected from updated 90-day compliance report thru web enabled online RESMED AIRVIEW’s secure database. Initial follow-up for Group1 was in 4 weeks and/or earlier if patient initiated and for Group2 in 2–3 days following PAP set up. Additionally, non-compliant patients in Group2 received monthly follow-ups.

Results

Following findings were reported for Group1 - (Male=24, Female=26), mean age 65.79±13.21, and BMI 36.12±7.50; and Group2 - (Male=25, Female=25), mean age 62.8±12.32, and BMI 36.90±9.29. During diagnostic testing >50% patients in both groups rated their overall sleep to be worse than usual. Compliance for Group1 was significantly worst than Group2 (64% and 91%, respectively). Group1 had 8=AHI≥5, 29=AHI≤5 and had 13 lost to followup (11 behavioural in-adaptations, 2 financial constrains) soon after commencing CPAP. Group2 had 3 lost to financial constraints, 4=AHI≥5, and 43=AHI<5. Chi-square (5.4265) indicated p-value=.019, chi-square Yates-correction (4.502) calculated p-value=.033. Significant at p<.05, Chi-square test revealed dependant relationship between PAP unsatisfactory patient evaluation during diagnostic polysomnography to PAP non-compliance. Group1’s RR=3 and OR=4.45; Group2’s RR=0.33 and OR=0.22, indicated higher probability of non-compliance in Group1.

Conclusion

Provider-patient contact within 2–3 days versus any other intervals (4 weeks mandatory and/or as needed in this case), soon after commencing PAP therapy not only increases compliance efficacy but also reduces patient dropouts and anxiety with PAP therapy. Considerable fraction of patients are uncomfortable using CPAP; therefore, closer follow-ups versus 4 weeks is warranted to maintain CPAP adherence.

Support (if any):
447 Cost-Effectiveness of a 3-Year Tele-OSA Intervention
Authors: An Jaejin , Hwang Dennis , Shi Jiaxiao , Sawyer Amy , Chen Aiyu , Mazzotti Diego , Maislin Greg , Keenan Brendan , Arguelles Jessica , Pack Allan , Glick Henry
Published: May 2021

Introduction

Trial-based tele-obstructive sleep apnea (OSA) cost-effectiveness analyses have often been inconclusive due to small sample sizes and short follow-up. In this study, we report the cost-effectiveness of Tele-OSA using a larger sample from a 3-month trial that was augmented with 2.75 additional years of epidemiologic follow-up.

Methods

The Tele-OSA study was a 3-month randomized trial conducted in Kaiser Permanente Southern California that demonstrated improved adherence in patients receiving automated feedback messaging regarding their positive airway pressure (PAP) use when compared to usual care. At the end of the 3 months, participants in the intervention group pseudo-randomly either stopped or continued receiving messaging. This analysis included those participants who had moderate-severe OSA (Apnea Hypopnea Index >=15) and compared the cost-effectiveness of 3 groups: 1) no messaging, 2) messaging for 3 months only, and 3) messaging for 3 years. Costs were derived by multiplying medical service use from electronic medical records times costs from Federal fee schedules. Effects were average nightly hours of PAP use. We report the incremental cost per incremental hour of PAP use as well as the fraction acceptable.

Results

We included 256 patients with moderate-severe OSA (Group 1, n=132; Group 2, n=79; Group 3, n=45). Group 2, which received the intervention for 3 months only, had the highest costs and fewest hours of use and was dominated by the other two groups. Average 1-year costs for groups 1 and 3 were $6035 (SE, $477) and $6154 (SE, $575), respectively; average nightly hours of PAP use were 3.07 (SE, 0.23) and 4.09 (SE, 0.42). Compared to no messaging, messaging for 3 years had an incremental cost ($119, p=0.86) per incremental hour of use (1.02, p=0.03) of $117. For a willingness-to-pay (WTP) of $500 per year ($1.37/night), 3-year messaging has a 70% chance of being acceptable.

Conclusion

Long-term Tele-OSA messaging was more effective than no messaging for PAP use outcomes but also highly likely cost-effective with an acceptable willingness-to-pay threshold. Epidemiologic evidence suggests that this greater use will yield both clinical and additional economic benefits.

Support (if any)

Tele-OSA study was supported by the AASM Foundation SRA Grant #: 104-SR-13
452 Patient Factors and Preferences in Decision for Sleep Surgery: A Qualitative Analysis
Authors: Ikeda Allison , Marsh Robin , McShay Crystina , Saini Shireen , Sardesai Maya , Weaver Edward , Boss Emily
Published: May 2021

Introduction

Patients with obstructive sleep apnea (OSA) are offered many treatment options spanning the spectrum of lifestyle modification, device therapy, and surgery. Sleep surgery, while often effective, results in moderate morbidity and has variable effectiveness on OSA improvement. Little is known about what patients consider when choosing treatment. We aim to identify factors that influenced the decision for sleep surgery among adults with OSA.

Methods

We conducted semi-structured virtual interviews with patients (≥18 years) with OSA (apnea-hypopnea index ≥5 events per hour of sleep) who underwent sleep surgery at a tertiary academic center, querying patients about factors in their decision for OSA treatment. Interviews were audio-recorded, transcribed, and analyzed for thematic content. We anticipate enrolling 10–18 total participants based on previously reported sample size in specialty groups for thematic saturation in specialty groups (ie, when no new concepts or factors emerge from interviews). Here we report pilot qualitative analysis results.

Results

Of nine eligible patients, eight enrolled (mean +/- standard deviation age 45.8 +/- 13.4 years, 2 female/6 males). Four patients underwent nasal surgery only, two patients underwent staged procedures, one underwent pharyngeal surgery only, and the last underwent nasal surgery with tori removal. Patients reported decision making duration of days to years for scheduling surgery. Reasons for pursuing sleep surgery included fatigue, quality of life, work performance, and safety. Overarching thematic domains related to decision for surgery were (1) major concerns, (2) external factors influencing decision, and (3) retrospective satisfaction/regret with decision. Major concerns involved factors beyond surgeon’s control, such as anesthesia and postoperative pain management, not surgery itself. Family and friends were reported to be highly influential in the process, both in favor and against surgery. Social media features and celebrity patients with OSA heightened awareness of sleep surgery and set preconceived expectations. Patients were mostly satisfied with outcomes, despite unanticipated acute recovery challenges.

Conclusion

This pilot qualitative analysis identifies factors influencing patients’ OSA treatment decisions. Understanding patients’ major concerns and sources of information may help to guide physician counseling, set realistic expectations, offer peri-operative support, and better engage parents in shared decision-making for sleep surgery.

Support (if any)

None.
455 Obesity modifies the effect of 4 months of CPAP on glucose levels in adults with obstructive sleep apnea
Authors: Pak Victoria , Maislin David , Keenan Brendan , Townsend Raymond , Benediktsdottir Bryndis , Guo Xiaofeng , Pack Allan , Gislason Thorarinn , Kuna Samuel
Published: May 2021

Introduction

Continuous positive airway pressure (CPAP) therapy may improve insulin sensitivity and glucose tolerance seen in individuals with obstructive sleep apnea (OSA), however there is a lack of studies on whether obesity modifies the effect. We examined the baseline and follow-up levels of insulin and glucose following 4 months of CPAP treatment among participants with body mass index (BMI) <30, 30≤ BMI<35, and BMI≥35 kg/m2.

Methods

We identified 221 adults (84% males) with newly diagnosed OSA in the Penn Icelandic Sleep Apnea (PISA) Study, with a mean (±SD) BMI 31.7 +- 4.2 kg/m2 and apnea-hypopnea index (AHI) of 35.7+-15.6 events/hour. Associations between changes in natural log of the biomarkers within BMI groups were explored, controlling for a priori baseline covariates of age, baseline BMI, race, sex, site, and current smoking status.

Results

The mean proportional change (from baseline to follow-up) in log-transformed glucose in CPAP adherent participants was significantly larger in the BMI ≥35 and 30≤ BMI<35 groups compared to BMI <30. Within the BMI ≥35 group, the baseline to follow up increase in glucose post-CPAP was 1.08 (95% CI 1.01–1.15), while there were no significant changes in the other 2 BMI groups. A mediation analysis was performed with models including BMI change, and glucose was found to be significantly different between groups. There was no statistically significant association for insulin.

Conclusion

Our findings show that obesity modifies the effect of four months of CPAP on glucose levels.

Support (if any)

1P01-1HL094307
458 The effect of cardioversion therapy for atrial fibrillation on AHI in obstructive sleep apnea patients
Authors: Zakhary Nardine , Mehra Reena , Monahan Ken , Sahadevan Jayakumar , May Anna
Published: May 2021

Introduction

Sleep apnea (SA) is known to be associated with development of atrial fibrillation (AF), and therapy ameliorates this risk. Case reports and small series raise the possibility of a bidirectional effect of AF on SA burden. We hypothesize that SA control, demonstrated either by residual apnea-hypopnea index (AHI) or pressure during positive airway pressure (PAP) therapy, improves after successful cardioversion.

Methods

The cohort included VA patients with SA on PAP therapy who underwent successful outpatient direct-current AF cardioversion. Only patients with good adherence in the peri-procedural period, defined as use most days in the week before and after procedure, were included in the study (n=17). We compared AHI prior to and after cardioversion using the sign test since values were not normally distributed. Since most participants were on auto-titrating PAP, the sign test was also used to compare mean pressure difference in the 7 days before and after the procedure.

Results

There was no statistical difference when comparing AHI before and after AF cardioversion therapy (AHI change = -0.45, 95% CI = [-0.94, 0.17]) There was also no difference between mean pressure used for PAP therapy before and after therapy (pressure change = 0.05, 95% CI = [-0.1, 0.33]).

Conclusion

This small study did not find an association between successful AF cardioversion and PAP residual AHI or pressure (for auto-titrating machines). A larger cohort may have improved power to detect subtle effects of AF therapy on SA burden.

Support (if any)

This study was supported by the Career Development Award IK2CX001882 from the United States (U.S.) Department of Veterans Affairs Clinical Sciences Research and Development Service.
486 Timing and Duration of Adverse Events in a Clinical Trial of Lower-Sodium Oxybate in Participants With Narcolepsy With Cataplexy
Authors: Bogan Richard , Foldvary-Schaefer Nancy , Skowronski Roman , Chen Abby , Thorpy Michael
Published: May 2021

Introduction

This analysis evaluated treatment-emergent adverse events (TEAEs) during a double-blind, placebo-controlled, randomized withdrawal trial (NCT03030599) of lower-sodium oxybate (LXB; Xywav™), an FDA-approved treatment for excessive daytime sleepiness or cataplexy in narcolepsy.

Methods

At study entry, participants were taking sodium oxybate (SXB) alone, SXB with other anticataplectics, other anticataplectics alone, or were anticataplectic treatment-naive. Participants taking SXB transitioned to the same LXB dose (gram-for-gram); oxybate-naive participants initiated LXB (4.5 g/night). TEAEs were analyzed in the safety population (N=201, received ≥1 study drug dose) during a 12-week open-label optimized treatment/titration period (while other anticataplectics were tapered/discontinued) and subsequent 2-week stable-dose period (SDP). TEAE duration was defined as time from TEAE start to end date (or end of SDP, if TEAE end date was unrecorded).

Results

LXB-emergent TEAEs varied by treatment at entry. Anticataplectic treatment-naive participants reported TEAEs including headache (n=36/90, 40%; median duration [range]=1 [1–76] day), nausea (n=19/90, 21%; duration=9 [1–37] days), and dizziness (n=15/90, 17%; duration=10 [1–117] days); peak incidence was week 2 (n=8/89, 9%) for headache, week 3 (n=3/88, 3%) for dizziness, and week 1 (n=6/90, 7%) for nausea. Anticataplectic treatment-naive participants (n=13/90, 14%) also reported decreased appetite, with relatively long duration (58 [2–358] days). Participants taking SXB alone reported TEAEs including headache (n=17/52, 33%; duration=1 [1–122] day) and diarrhea (n=4/52, 8%; duration=41 [2–101] days); peak headache incidence was week 4 (n=4/52, 8%); diarrhea had no peak. Participants taking other anticataplectics alone reported TEAEs including headache (n=14/36, 39%; duration=1 [1–94] day), nausea (n=9/36, 25%; duration=3 [1–16] days), and dizziness (n=9/36, 25%; duration=4 [1–29] days); peak incidence was week 1 (n=3/36, 8%) for headache, week 6 (n=2/32, 6%) for nausea, and week 4 (n=3/33, 9%) for dizziness. One participant taking SXB with other anticataplectics (n=1/23, 4%) reported headache in weeks 1–2 and 4; one reported nausea (4%) persisting from week 1 to 8. Overall, study discontinuations attributed to TEAEs were 20/57 (35%).

Conclusion

Most TEAEs with LXB treatment occurred early, were consistent with the known SXB safety profile, and were relatively short-lived (except decreased appetite). Participants previously taking SXB reported fewer TEAEs than oxybate-naive participants.

Support (if any)

Jazz Pharmaceuticals, Inc.
488 REST-ON: Efficacy of FT218 for Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients With Narcolepsy
Authors: Thorpy Michael , Roth Thomas , Dauvilliers Yves , Kushida Clete , Shapiro Colin , Corser Bruce , Ajayi Akinyemi , Dubow Jordan , Seiden David , Rosenberg Russell
Published: May 2021

Introduction

Sodium oxybate (SO) is an effective treatment for narcolepsy; however, currently available formulations must be taken twice nightly. FT218 is an investigational once-nightly controlled-release formulation of SO. Here, we evaluated the efficacy of FT218 on excessive daytime sleepiness (EDS), self-reported sleep quality/refreshing nature of sleep, sleep paralysis (SP), and hypnagogic hallucinations (HH) in patients with narcolepsy.

Methods

In this phase 3, randomized, double-blind, placebo-controlled, multicenter study, patients aged ≥16 years with narcolepsy type 1 or 2 were randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night (1 week), 6.0 g/night (2 weeks), 7.5 g/night (5 weeks), and 9.0 g/night (5 weeks). Secondary efficacy endpoints included EDS using the Epworth Sleepiness Scale (ESS), sleep quality/refreshing nature of sleep using a visual analog scale (VAS), and SP and HH using a sleep symptom diary.

Results

A total of 212 patients were randomized and received study medication (FT218, n=107; placebo, n=105). Patients receiving FT218 had significant improvement vs placebo in EDS on the ESS: LS mean difference on ESS score between FT218 and placebo was −3.86 for 9.0 g (week 13), −3.16 for 7.5 g (week 8), and −2.06 for 6.0 g (week 3) (all P<0.001). Sleep quality/refreshing nature of sleep on VAS was also significantly improved with FT218 vs placebo (P<0.001 for all doses). Patients receiving FT218 reported less SP vs placebo (P<0.05 at all doses). Baseline values for HH were low in both treatment groups; HH was similar for both treatment groups at all study visits. The most common adverse reactions were nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.

Conclusion

At all evaluated doses, treatment with FT218 significantly improved EDS, sleep quality/refreshing nature of sleep, and SP vs placebo. FT218 was generally well tolerated; the most common adverse events were consistent with known SO side effects.

Support (if any)

Avadel Pharmaceuticals.
492 Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Stimulant Use: A Post Hoc Analysis From the REST-ON Study
Authors: Roy Asim , Morse Anne Marie , Dubow Jordan , Seiden David , Bogan Richard
Published: May 2021

Introduction

FT218 is an investigational, once-nightly, controlled-release formulation of sodium oxybate for the treatment of narcolepsy. The purpose of this post hoc analysis of the REST-ON study was to evaluate the effect of FT218 on measures of excessive daytime sleepiness (EDS) in patients with narcolepsy with or without stimulant use.

Methods

This was a randomized, double-blind, placebo-controlled, multicenter study in patients with narcolepsy ≥16 years old. Patients were stratified by stimulant use and randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night for 1 week, 6.0 g/night for 2 weeks, 7.5 g/night for 5 weeks, and 9.0 g/night for 5 weeks (maximum treatment duration, 13 weeks). Assessments of EDS included mean sleep latency (minutes) on maintenance of wakefulness test (MWT) and Clinical Global Impression-Improvement (CGI-I) in sleepiness.

Results

A total of 190 patients were included in the modified intent-to-treat population (stimulants: FT218, n=66; placebo, n=53; no stimulants: FT218, n=31, placebo, n=40). Overall, 63% of patients were on concomitant stimulants. Patients receiving FT218 had significant improvement vs placebo in MWT regardless of stimulant use. LS mean difference in mean sleep latency vs placebo for stimulant use was 5.99 for 9.0 g (week 13), 5.51 for 7.5 g (week 8), and 5.35 for 6.0 g (week 3; all P<0.001). For no stimulant use, LS mean difference was 6.28 for 9.0 g (P=0.001), 7.14 for 7.5 g (P<0.001), and 4.19 for 6.0 g (P=0.007). More patients receiving FT218 rated sleepiness as much/very much improved on CGI-I vs placebo (stimulant use: 9.0 g, 80.5% vs 35.3%, odds ratio [OR] 7.55; 7.5 g, 66.3% vs 26.5%, OR 5.44; 6.0 g, 39.8% vs 4.4%, OR 14.27 [all P<0.001]; no stimulant use: 9.0 g, 55.1% vs 27.2%, OR 3.29 [P=0.047]; 7.5 g, 54.5% vs 17.5%, OR 5.64 [P=0.006]; 6.0 g, 40.0% vs 7.7%, OR 8.04 [P=0.003]). FT218 was generally well tolerated.

Conclusion

FT218 had similar efficacy on EDS at all evaluated doses in narcolepsy patients with or without stimulant use, with improvement over placebo on MWT and CGI-I. FT218 may provide effective treatment for EDS in patients with narcolepsy regardless of stimulant use.

Support (if any)

Avadel Pharmaceuticals.