bluuebunny/crossref_metadata_2025 huggingface dataset:
0422 Cognitive Behavioral Therapy for Insomnia: The First Line Treatment for Insomnia Remains Elusive
Authors: Floyd Veronica , Turney Cameron , Assar Arash , Dickens Harrison , Egeler Mara , Walker Jamie , Vargas Ivan
Published: April 2024

Introduction

Cognitive Behavioral Therapy for Insomnia (CBT-I) is a highly efficacious behavioral intervention for insomnia. However, no one has quantified to what extent United States citizens are familiar with or have used CBT-I (compared to other treatments like medication). This descriptive analyses study assessed the proportion of Americans that were familiar with and have used forms of sleep intervention, including CBT-I.

Methods

3,082 participants across the United States were surveyed through Cloudresearch Connect. The mean age was 39.6 (Range = 18-85). The sample comprised of 48.7% women and 71.3% identified as White. Participants were asked (on a 7 point Likert scale) questions about sleep health. Participants were asked about their familiarity with insomnia treatments including: prescription and over-the-counter (OTC) medications, Melatonin, CBTI, Sleep Hygiene, Sleep Restriction Therapy (SRT), Stimulus Control Therapy (SCT), Relaxation or Mindfulness Meditation Therapy, and Light Therapy. Participants were asked if they had used any treatments prior to or within the past 12 months. Participants also completed the Insomnia Severity Index (ISI).

Results

Participants rated the importance of sleep on their physical (M = 6.2; SD = 0.99) and mental (M = 6.4; SD = 0.96) health. 52.7% of the participants had at least subthreshold insomnia (ISI score < 8). 17.7% had clinically elevated insomnia (ISI score > 15). As for familiarity with various sleep treatments, 65.5% recognized prescription medications (e.g., Ambien), 69.3% recognized OTC medications (e.g., antihistamines), 80.5% recognized melatonin, 15.1% recognized CBT-I, 26% recognized sleep hygiene, 4.4% recognized SRT, 5% recognized SCT, 47% recognized Relaxation or Mindfulness Meditation Therapy, and 26.4% recognized Light Therapy. Among participants with at least subthreshold levels of insomnia, only 3.6% used CBT-I in the past 12 months, and 5% had used it at least once. In the past 12 months, 49.2% had used OTC medication and 13.8% had used prescription medications.

Conclusion

The data shows that CBT-I remains under-utilized. The majority of participants only knew of medication (prescription and OTC) treatments for insomnia. Efforts to identify and address the barriers to increasing awareness and availability of CBT-I are important and could help struggling insomniacs compared to other methods previously attempted.

Support (if any)
0423 Insomnia Management Program in Primary Care Can Improve Subjective Sleep Quality and Insomnia Severity Index (ISI)
Authors: Hussaini Fareeha , Stachura Amanda , Szalacha Laura , Canalejo Lilly
Published: April 2024

Introduction

Insomnia is the most common sleep disorder affecting up to 30% of the US population with Chronic Insomnia at 10%. Cognitive behavioral therapy for insomnia (CBT-I) has been recommended as the first line treatment and standard of care by the American College of Physicians and American Academy of Sleep Medicine. The goal of CBT-I is to help remedy symptoms and improve sleep quality with the aim of eliminating the reliance on prescription medications. Nonetheless, the use of CBT-I is limited while the use of sleep medications remains high, up to 8% of the US population. The aim of this pilot was to test the use of self-guided CBT-I using mobile app (CBT-I Coach) to reduce chronic insomnia and decrease the need for new sleep aide prescriptions.

Methods

The one-arm pilot was conducted in a diverse, large university-based family medicine practice. Family medicine providers (n=11) received education on insomnia and recommended primary management with CBT-I. Patient recruitment was completed in 8 weeks and included both referrals and from chart reviews (ICD 10 codes for insomnia). Participants received sleep education including sleep hygiene education and insomnia management with a CBT-I mobile app.

Results

The 23 participants, aged 25 to 64, reported significant improvement in ISI from moderate to sub-threshold insomnia (baseline M=19.26, SD=3.60 to final M= 14.04, SD=7.0, paired t-test=4.47, df=22, p<.001, Cohen’s d=.93). In response to the intervention, 54.5% assessed their insomnia as “improved”, 36.4% as “stable”, and only 9.1% as "worse.” 71.4% of those taking prescribed medications rated their insomnia as “stable”, 66.7% of those taking Melatonin rated their insomnia as “improved” and 66.7% of those taking nothing at all rated their insomnia as “improved.” Notably, for those taking any sleep aide or medication, there was neither an increase in dosage nor a new prescription during this study.

Conclusion

Primary care implementation of a self-guided insomnia management program delivered through the app CBT-I Coach can improve sleep quality and insomnia severity. This intervention can especially be beneficial for those taking nonprescription sleep aide (melatonin) or no medication at all.

Support (if any)
0424 Evaluating Sedative-Hypnotics Education Across Diverse Communities Using Community Alignment Theory
Authors: Chang Jungchen , Hsieh Yow-Wen , Wu Chen-I , Hsu Kaifanf , Hung Hsiao-Mei , Li Chun-Ta , Chen You-An , Wang Tzu-Chueh , Ting Hsien-wei , Chang Fong-Ching , Chi Hsueh-Yun
Published: April 2024

Introduction

Since the late 1990s, misuse of prescription sedative-hypnotics like benzodiazepines (BZDs) and non-benzodiazepines (non-BZDs) has surged, becoming a significant public health issue. To address this, a community health program was evaluated for its effectiveness in raising awareness, providing preventive education, and implementing interventions. The study assessed a comprehensive health promotion initiative involving healthcare providers, trained community members, and volunteers to encourage responsible use of sedative-hypnotics among diverse populations.

Methods

The study employed Community Alignment Theory to emphasize the significance of cohesive collaboration among community members, organizations, and institutions, aiming to achieve sustainable and impactful outcomes. Eight experienced institutions across various regions, proficient in implementing individual and population health education programs, were selected with support from academic universities and non-governmental organizations (NGOs). These entities actively participated in developing and executing comprehensive programs. To assess awareness regarding the accurate use of sedative-hypnotics, five-item questionnaires were developed. These questionnaires exhibited a high content validity index of over .85, determined by eight experts, and demonstrated strong internal consistency reliability of .89.

Results

Eight institutions across diverse regions collaborated with 161 stakeholders and enrolled 875 participants, comprising 447 males (51.1%) with an average age of 58.3 ± 17.6 years. The current prevalence of insomnia, occurring at least three days a week, stood at 15.2% (n=133), with over half of the participants (n=466, 53.3%) having sought medical assistance for insomnia. Following the execution of 646 educational programs conducted in 275 locations and 13,348 participants attended, there was a significant improvement in awareness regarding insomnia and the appropriate utilization of sedative-hypnotics (p<.001). This enhancement encompassed various aspects such as daytime naps, sleep hygiene, prescription adherence, and awareness of hypnotics' adverse effects.

Conclusion

The utilization of the community alignment theory serves as a fundamental framework for steering educational initiatives within communities, demonstrating advantageous impacts on promoting the precise utilization of sedative-hypnotics.

Support (if any)

The Food and Drug Administration, Ministry of Health and Welfare, Taiwan, supported the study (Project number MOHW112-FDA-D-114-000641).
0427 Assessment of First-Night Effect in Patients with Insomnia Using the Odds-Ratio-Product (ORP)
Authors: Lambing Kari , Guadagni Veronica , Gerardy Bethany , Bender Amy , Younes Magdy , Bastien Celyne
Published: April 2024

Introduction

Studies on first-night effect using conventional sleep metrics have been inconclusive. ORP is an objective index of sleep depth and wake propensity ranging from 0 (very deep sleep) to 2.5 (full wakefulness). ORP provides more in-depth information about sleep. We compared several ORP-derived metrics measured during three consecutive PSGs in patients with and without insomnia.

Methods

Participants (n=119) were screened with the Insomnia Severity Index and clinical interviews and assigned to either control (n=50) or insomnia (n=69) groups. Participants completed 3 nights of in-laboratory polysomnography. After each PSG, participants answered the question “How was your night in the lab compared to a night at home?” on a 1 (much better) to 5 (very mediocre) scale. The following variables were compared across the three nights with repeated-measures ANOVA. Questionnaire response (Q); average ORP during stages wake (ORPW), NREM (ORPNR) and REM (ORPREM) sleep; percent of recording time in deep sleep (ORP< 0.5) and in full wakefulness (ORP>2.25); average instantaneous difference between right and left ORP (R/L ORP difference), a measure of interhemispheric dissociation in sleep depth; frequency (hr-1) of transient increases (>2.0) in ORP during NREM sleep (WII); along with total sleep time (TST), % time awake (%wake), minutes in stages NREM3 (N3 time) and REM sleep (REM time); arousal index (AI).

Results

There were no differences between nights 2 and 3 in any variable. Q decreased beyond night-1, indicating improvement relative to home. The following significant changes were observed in night-2 in both insomnia and control groups (Tukey’s test): ORPNR and ORPREM decreased (deeper sleep); more time in deep sleep (ORP< 0.5) and less time in full-wakefulness (ORP>2.25); less WII. The following significant changes were observed in night-2 only in participants with insomnia: Lower ORPW, indicating less alertness during stage W, and less R/L ORP differences. TST marginally increased and N3 time and AI marginally decreased in insomnia while %wake decreased marginally in both groups.

Conclusion

This study demonstrated clear first-night effects in several EEG microstructure variables in both control and insomnia participants, while the latter also showed reduced alertness and improved R/L agreement in sleep depth beyond night-1.

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0429 Sleep Misperception in Insomnia Phenotypes Based on Objective Sleep Duration in Young Adults
Authors: Atha Raegan , Lenker Kristina , Calhoun Susan , Liao Jason , Vgontzas Alexandros , Liao Duanping , Bixler Edward , Fernandez-Mendoza Julio
Published: April 2024

Introduction

Prior research has suggested that the underestimation of total sleep time (TST), i.e., so-called sleep misperception, may be a trait feature of those with insomnia. Prior studies have also shown differences in the degree of sleep misperception across insomnia phenotypes, however, these findings have not been replicated in population-based samples of young adults.

Methods

We studied 270 young adults (median 25 years, 53% female, 24% racial/ethnic minority) from the Penn State Child Cohort who underwent a 9-hour polysomnography (PSG) recording, clinical history, and self-report surveys. Insomnia symptoms were defined as reports of difficulties initiating or maintaining sleep, insomnia diagnosis or complaint, and/or sleep medication use. PSG-measured short sleep duration was defined by the median of the sample (i.e., < 7-h), identifying normal sleep duration (NSD), short sleep duration (SSD), insomnia with normal sleep duration (INSD) and insomnia with short sleep duration (ISSD). Subjective TST was ascertained from a morning questionnaire completed immediately upon awakening from the PSG as well as from a retrospective survey of habitual sleep at home. A general linear model tested mean differences in TST-discrepancy across the four groups, while adjusting for sex, race/ethnicity, age, waist circumference, sleep apnea, cardiometabolic disorders, medication and substance use.

Results

INSD consistently underestimated TST, regardless of whether it was assessed upon awakening in the lab (-37.9±7.7 min; p< 0.001) or by reports of habitual sleep (-41.5±9.1 min; p< 0.001), while ISSD showed relative accuracy when TST was assessed upon awakening in the lab (8.9±7.8 minutes) and clear overestimation (85.9±9.2 minutes) when assessed by reports of habitual sleep.

Conclusion

Sleep misperception is a trait feature of individuals with INSD, who underestimate their sleep duration regardless of method of measurement used. These data suggest that the INSD phenotype may respond better to therapies addressing the cognitive and cortical underpinnings of this phenomenon.

Support (if any)

NIH (R01 HL136587, R01 MH118308, UL1 TR00127)
0434 Effect of Dynamic Binaural Beats on Sleep Quality: A Proof-of-Concept Study with Questionnaire and Biosignals
Authors: Paik Sang Min , Lee Hwa Ah Ni , Park Hyo Jin , Han Sun-Kyu , Kim Jae Rim , Lee Woo-Jin , Hwang Han-Jeong , Yun Chang-Ho
Published: April 2024

Introduction

The key pathomechanism of insomnia involves hyperarousal, which increases anxiety, stress, and alertness during the pre-sleep initiation period and interferes with the ability to initiate or maintain sleep. Hyperarousal is associated with disrupted autonomic nervous system (ANS) regulation during the process of sleep initiation. Binaural beat (BB) sounds subjectively perceived by listeners when each ear is presented with a small frequency difference. BB has been investigated as a potential modality to enhance sleep quality and to reduce sleep latency. In this study, we introduce a new form of BB, referred to as dynamic BB (DBB), which incorporates dynamically changing carrier frequency differences between the left (fixed at 100 Hz) and right (oscillates between 100-103 Hz) ears, yielding a frequency difference range of 0 to 3 Hz. We evaluated the effects of DBB on sleep quality using polysomnography (PSG) parameters, electroencephalography (EEG), and ANS function regulation measured using heart rate variability (HRV).

Methods

Ten healthy participants were included in a cross-over design, where they experienced both DBB and a SHAM (absence of sound) condition across two consecutive nights, with PSG evaluation. DBB was administrated during pre-sleep initiation, sleep onset, and transition from rapid-eye-movement (REM) to non-REM stage (non-REM transition). Sleep latency, sleep efficiency, relative portion of each sleep stage on PSG, relative power of each frequency band in EEG, and mean HRV and its low/high frequency power were compared to evaluate the effect of DBB.

Results

DBB significantly reduced sleep latency as well as marginally increase sleep efficiency compared to the SHAM condition. Moreover, HRV was significantly lower for the DBB condition than the SHAM condition in both pre-sleep initiation and sleep onset periods, and LF power did in sleep onset period, indicating its ability to suppress the activity of the sympathetic nervous system—associated with arousal—and to enhance the parasympathetic nervous system, consequently facilitating a swifter transition into sleep.

Conclusion

DBB might be effective in improving the sleep quality, suggesting its possible application in insomnia treatments.

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0435 Continuous Theta-burst Stimulation Lowers the Impact of Anxiety on Sleep Duration in Individuals with Insomnia
Authors: Desai Shivani , Reich-Fuehrer Melissa Melissa , Huskey Alisa , Yakpogoro Nekabari , Henderson-Arredondo Kymberly , Patel Salma , Jankowski Samantha , Trapani Christopher , Hildebrand Lindsey , Franca Gabriela , Grandner Michael , Chen Yu-Chin (Allison) , Chou Ying-Hui , Dailey Natalie , Killgore William
Published: April 2024

Introduction

Repetitive Transcranial Magnetic Stimulation (rTMS) is a procedure by which a magnetic coil is used to stimulate specific regions of the brain to bring about alterations in function. Continuous theta-burst stimulation (cTBS) is a form of rTMS that was used to suppress cortical excitability and lower within network connectivity in the Default Mode Network (DMN). Connectivity within the DMN is associated with rumination and mind-wandering. Prior research indicates that pre-sleep anxiety is associated with increased sleep latency and decreased sleep continuity. As part of a larger project, we hypothesized that pre-sleep anxiety would negatively impact total sleep time, as measured by polysomnography (PSG), but that this effect would be reduced or eliminated in the active cTBS condition compared to sham.

Methods

We administered cTBS to 20 participants with insomnia symptoms (Nmales = 8, Mage=31.6, SD=6.7) (Nfemales =12, Mage=23.8, SD=4.3). Participants then underwent one administration of sham stimulation and one administration of active cTBS to the left angular gyrus node of the DMN in a randomized order separated by one week. The State Trait Anxiety Inventory (STAI-S) was administered immediately before each session, and PSG data was collected during overnight laboratory stays following the TMS sessions. We ran two linear regressions between STAI-S scores and total sleep time - one analysis for the sham condition and another for the active condition.

Results

Elevated STAI-S scores (M=41.6, SD=6.984) predicted decreased total sleep time (Mean minutes=393.75, SD=48.45) for the sham cTBS condition (F(1,18)=8.689, p=.009; β=-.571, p=.009). In contrast, the relationship between STAI-S scores (M=40.9, SD=50.35) and total sleep time (Mean minutes=403.8, SD=5.34) was not significant for the active cTBS condition (F(1,18)=2.409, p=.138; β=-.344, p=.138).

Conclusion

Prior data presented from this trial revealed that active cTBS improved TST overall. However, here we further demonstrated that higher pre-sleep anxiety predicted a lower sleep duration for the sham cTBS condition but not for the active cTBS condition, suggesting that the active cTBS may mitigate the effects of anxiety on sleep. These findings support the applicability of continuous theta-burst stimulation in treating psychiatric conditions related to sleep difficulties, such as anxiety.

Support (if any)

US Army Medical Research Acquisition Activity Grant: W81XWH2010173
0436 Combining Insomnia Therapy with Sleep Tracking Using Wearables: Effects of a CBT-I-based App on Sleep - A RCT Study
Authors: Hinterberger Alexandra , Eigl Esther-Sevil , Schwemlein Robyn , Topalidis Pavlos , Schabus Manuel
Published: April 2024

Introduction

Due to the gap in non-pharmacological insomnia treatment, effective and validated digital solutions are urgently needed. So far, digital cognitive behavioral therapy for insomnia (CBT-I) options are comprised of a therapy program and subjective measurements in form of a sleep diary. Objective sleep measurements are usually not included. Here, we evaluate an innovative smartphone app (NUKKUAA®), combining i) a CBT-I-based sleep training with ii) subjective as well as iii) objective sleep monitoring via a wearable heart rate (HR) sensor, and iv) feedback based on such objective data. A RCT study was conducted to investigate effects on sleep and subjective-objective sleep discrepancies (SOSD).

Methods

Fifty-seven self-reported poor sleepers (20-76 years; MAge=45.67±16.38; 39 female) were randomly assigned to an experimental group (EG, n=28) or a waitlist control group (CG, n=29). During a 6-week intervention phase, the EG used the CBT-I-based app program including subjective and objective sleep monitoring as well as feedback on their sleep, while the CG used sleep monitoring only. Sleep was measured i) subjectively with questionnaires (Insomnia Severity Index, ISI; Pittsburgh Sleep Quality Index, PSQI), ii) objectively with ambulatory polysomnography (PSG), and iii) continuously via a HR sensor and sleep diaries.

Results

Analyses revealed interactions for ISI (p=.003, ƞ2part=.11) and PSQI (p=.050, ƞ2part=.05), indicating training-specific improvements for EG, yet not for CG. While PSG-derived outcomes appear to be less training-specific, a tendential reduction in wake after sleep onset (WASO) was found in EG (p=.061, d=0.55). Regarding changes in SOSD, results indicate a SOSD reduction during intervention for total sleep time in both groups, while improvements for sleep efficiency, sleep onset latency and WASO were found in EG only (p’s≤.022, d≥0.46).

Conclusion

The findings indicate beneficial effects of an innovative smartphone app on sleep and SOSD. More scientific evaluation of such digital programs is needed in order to ultimately help reducing the gap in non-pharmacological insomnia treatment and provide affected individuals with sufficient treatment options and effective, low-threshold support for their sleep problems.

Support (if any)

PT was partly supported by the FWF/Austrian Science Fund (W 1233-B).
0438 Optimizing Virtual Insomnia Therapy for Women: Insights from an Insomnia Pilot Program in Australia
Authors: Lee Bao Hui , Gan Hui Leng , Medalie Lisa , Wimms Alison
Published: April 2024

Introduction

Insomnia, a prevalent sleep disorder, poses unique challenges for women, often compounded by coexisting women’s health and mental health conditions. This study explores the accessibility and viability of a virtual insomnia therapy program tailored for women, leveraging cognitive behavioural therapy for insomnia (CBT-i) delivered via telehealth.

Methods

The pilot, conducted from May to August 2023, was advertised through email and social media campaigns. Basic demographic information and sleep issues were collected. Respondents were then given the opportunity to engage in a pilot program involving telehealth CBT-i sessions and digital sleep diaries. Information on women’s sleep attitudes and issues were collected. Participation rates, therapy adherence, and participant feedback were analysed to evaluate program effectiveness and identify barriers to therapy.

Results

61 women, predominantly aged 40 and above (90%), all experiencing sleep challenges for over three months responded to the campaign. Of the 61 women, five chose to actively engage in the pilot program. Of these, 1 completed treatment, 1 had trouble obtaining a GP referral, 2 dropped out due to travel/competing priorities, and 1 did not want to pay upfront out-of-pocket cost. Despite these challenges, the participants reported high satisfaction (average score: 8.9 out of 10) and a strong likelihood to recommend the program (Net Promoter Score: 100). Notably, all participants had coexisting women's health and mental health conditions, and 60% had a previous diagnosis of obstructive sleep apnea (OSA).

Conclusion

The pilot demonstrated the potential and challenges of engaging women with complex health needs in virtual CBT-i for insomnia through targeted advertising. Although satisfaction among participants was high, indicating its effectiveness, the modest engagement rate highlights the need for strategies that not only reach women but also enhance their understanding of insomnia and its treatment. This suggests that while targeted advertising is a promising approach for providing direct access to insomnia treatment, it needs to be complemented with other strategies, such as healthcare referrals and comprehensive psychoeducation about insomnia and CBT-i to enhance treatment access and adherence, especially for women with complex health needs.

Support (if any)

ResMed.
0441 Sleep Disturbance in MCI: A Pilot Study of a Cognitive Behavioural Therapy Digital Intervention (SUCCEED)
Authors: Hoyos Camilla , Espinosa Nicole , Marshall Nathaniel , LaMonica Haley , Gordon Christopher , Rainey-Smith Stephanie , Grunstein Ronald R , Naismith Sharon
Published: April 2024

Introduction

Insomnia is common in older adults with mild cognitive impairment (MCI) and predicts future cognitive decline. Cognitive Behavioural Therapy for insomnia (CBT-I) is the first-line treatment for insomnia but is often unavailable. We tested the feasibility of a randomised controlled trial comparing 12-weeks of digital CBT-I vs wait-listed control in older adults with MCI and insomnia.

Methods

This was an investigator-initiated (NCT05568381), parallel open-label randomised-controlled feasibility trial. Participants were randomised to digital CBT-I (Sleepio, 6-weekly sessions) or a wait-listed control (3 fortnightly online modules of a sleep health education package) via a secure centralised platform which was also used to collect the outcome data. This study was undertaken remotely without in-person visits. Potential participants were recruited through online advertising and a memory clinic in Sydney, Australia. Those who met initial eligibility were invited to a screening and informed consent telehealth consultation. Inclusion criteria included adults aged ≥50 years, with an Insomnia Severity Index (ISI)>10, who met the clinical criteria of MCI on a neuropsychological battery (performed over telehealth for participants recruited online). The primary outcomes were the proportion of participants who met screening and randomisation criteria. A secondary outcome was the effect sizes and 95%CIs of the difference in ISI between the groups at week 12.

Results

Recruitment occurred March 23, 2023 to August 11, 2023 stopping when we reached our pre-defined sample size (digital CBT-I=19; control=21; 30 females; mean [SD] age=59.7 years [7.3]; ISI=17.0 [3.7]). 37% of participants issued a pre-screening number (n=246), were eligible to attend online screening. 47% of those issued a screening number (n=90) were eligible to be randomised (n=42). All randomised participants (n=40) were recruited through the online pathway. At 12-weeks there was a difference in ISI between the digital CBT-I (mean±SE 7.8±1.1 points) and control groups (13.7±1.05 points) (Cohen’s D [95%CI] -1.6 [-2.4 to 2.1]). 79% of participants completed ≥4 out of the CBT-I 6 sessions. All adverse events were minor and transient.

Conclusion

This population can be recruited through online pathways and follow the protocol as well as adhere to the intervention of this remotely conducted trial.

Support (if any)

CogSleep CRE Seed Funding Grant. BigHealth- intervention in-kind.
0444 A Digital Therapy Based on Real-time Sleep Sensing Data
Authors: Ha Tae Kyoung , Lee Ho Dong , Lee Young Jun
Published: April 2024

Introduction

CBT-I has been known to be effective in treating insomnia. However, CBT-I showed problems such as shortage of medical staff and the need to visit the hospital several times. Therefore, CBT-I had implemented as digital CBT-I to overcome those demerits. However, it takes about over 6 weeks and is very tedious. In addition, it requires daily sleep diary to evaluate the efficacy of CBT-I treatment. These lowered patient’s compliance. To overcome this, a new digital CBT-I with sleep sensing device is proposed.

Methods

The proposed digital CBT-I was developed based on four basic ideas: (1) 17h of activity and 7h of sleep (2) discrepancy between desired time in bed (TIB) and desired total sleep time -DBST index (3) TIB during 24h and (4) taking sleeping pills 7h before wake-up time. The digital CBT-I consists of four weeks sessions: (1) sleep hygiene education (W0), (2) 17h of activity and 7h of sleep (W1), (3) educating about DBST index (W2), (4) TIB during 24h (W3), (5) final evaluation (W4). The clinical trial was a double-blind, randomized with 30 participants (15 test and 15 control) who were over ISI > 15 at W0. Conventional digital CBT-I were provided for control, and SOMNUM Scanning were used to record automatic sleep diary for all groups.

Results

ISI of test group were W0=18.9, W1=13.9, W2=12.0, W3=10.8, W4=10.2, and ISI of control group were W0=19.1, W1=16.1, W2=15.5, W3=14.2, W4=13.1. In terms of the proportion of participants whose ISI was reduced by < 15 at each visit, there was a significantly higher proportion in the test group than in the control group at W2 (83% vs. 43%,).

Conclusion

The results showed a significant improvement in ISI scores in both test and control groups. However, the mean ISI score of test group was significantly lower and the proportion of participants with ISI score below 15 points was also significantly higher at W2. This means that insomnia may improve at a faster rate when patients use the proposed this solution. This result also showed that automatic sleep diary recording by SOMNUM Scanning will be helpful to increase patient’s compliance.

Support (if any)
0445 Comparing Adherence for a Prescription Digital Therapeutic for Insomnia Across Controlled and Real-world Settings
Authors: Thorndike Frances , Gerwein Robert , Edington Samantha , Ong Jason , Riney Heidi , Ritterband Lee , Wickwire Emerson , Morin Charles
Published: April 2024

Introduction

Digital Cognitive Behavioral Therapy for insomnia (dCBT-I) offers scalable first-line treatment versus face-to-face care, but a potential trade-off is lower treatment adherence. In clinical trials, adherence rates to dCBT-I have been variable, and there is no defined standard for acceptable adherence to dCBT-I. Further, the generalizability of adherence data from clinical trials to real-world settings is unknown. This study compared adherence data from two dCBT-I clinical trials to adherence within a real-world study.

Methods

The dCBT-I intervention was a prescription digital therapeutic (Somryst) that includes 6 treatment Cores (e.g., sleep restriction, stimulus control) delivered over 9 weeks. Participants must complete a Core and wait 7 days before starting the next Core. Clinical trial adherence data was derived from two RCTs previously submitted to FDA as part of its authorization (RCT-1 [USA; N=151, age 21-65 years] and RCT-2 [Australia; N=574, age 18-64 years]). Real-world adherence data was derived from a prospective, single-arm, pragmatic clinical study (DREAM [USA; N=991, age ≥18 years]). Adherence was defined as the percentage of participants with dCBT-I access who completed each treatment Core. Automated notifications prompt engagement with the therapeutic.

Results

Real-world adherence rates from the DREAM study were 94.1%, 71.1%, 60.7%, 55.7%, 49.1%, and 42.8% for Cores 1-6. For RCT-1, adherence rates of Cores 1-6 were 93.4%, 88.1%, 76.8%, 67.5%, 66.9%, and 60.3%, respectively, whereas adherence rates of Cores 1-6 in RCT-2 were 80.8%, 67.9%, 60.5%, 54.0%, 47.6%, and 40.8%.

Conclusion

Real-world adherence to dCBT-I appears comparable to RCTs, with the largest decrease occurring between Cores 1 and 2. These findings support the generalizability of adherence data from RCTs and potential opportunities to increase adherence early in treatment. Further work is needed to determine acceptable standards for adherence to dCBT-I in the real world.

Support (if any)

DREAM study: Pear Therapeutics, Inc. RCT-1: NIMH grant #R01 MH86758; NCT01438697. RCT-2: NHMRC project grant #1005867; ACTRN12611000121965. Additional support provided by Nox Health, Inc.
0447 Uptake of Fully Automated Digital CBT for Insomnia in the Henry Ford Healthcare System: The First 100 Patients
Authors: Miller Christopher , Hirata Mika , Bradley Danielle , Blaine Arianna , Henry Alasdair , Hall Shana , Thomson Greig , Wood Ian , Kalmbach David , Drake Christopher
Published: April 2024

Introduction

Despite Cognitive Behavioral Therapy for Insomnia (CBT-I) being first line treatment for insomnia, primary care physicians typically treat insomnia with sleep hygiene or pharmacotherapy, but are unsatisfied with these approaches (Ulmer et al., 2017). Physicians may also lack knowledge about CBT-I (Dyas et al., 2010), or find it difficult to refer patients to receive therapist-delivered treatment due to a lack of trained providers (Haycock et al., 2021). Fully automated (without therapist support) digital CBT-I provides a solution with immediate, standardized, and convenient access for patients. This implementation project aims to embed evidenced-based digital treatment (Sleepio) in real world clinical practice within a large health care system (Henry Ford Health) and evaluate a novel clinical workflow.

Methods

Patients with insomnia who may benefit from CBT-I determined by their treating practitioner are offered Sleepio via the Epic electronic health records system at HFH Academic Internal Medicine (AIM) and Sleep clinics. Normalization Process Theory (May et al., 2016) was used to provide a framework to help embed digital CBT-I access. We report rates of electronic orders and Sleepio sign-ups for implementation and workflow acceptability. Leaflets and digital assets were distributed. Training sessions were also provided for clinicians at both the AIM and Sleep clinics. Email reminders helped promote access over time.

Results

As of December 13, 2023, N=565 electronic orders were placed by treating practitioners, and n=214 (38%) patients signed-up to start Sleepio (n=140 female, mean age=52.9 [range: 18-88]). The majority (84%) of patients were from sleep clinics. Adapting the electronic order process enabled clinicians to provide immediate digital access for patients. Senior staff training sessions at the sleep clinics were associated with a higher order rate across the Sleep clinics compared with the AIM clinic.

Conclusion

Fully-automated digital CBT for insomnia can be delivered as part of routine clinical care and electronic workflows with limited disruption to clinical practice. Normalization Process Theory enabled low-lift non-disruptive changes to clinical workflow over time allowing patients to obtain access to Sleepio. Training and reminding clinicians on how to introduce patients to a digital treatment helped increase uptake.

Support (if any)

n/a
0450 Genioglossus Motor Control During Mandibular Advancement and Inspiratory Resistive Loading
Authors: Jordan Amy , Dawson Andrew , Avraam Joanne , Thornton Therese , Nicholas Christian
Published: April 2024

Introduction

High activity of the genioglossus muscle is thought to prevent/resolve upper airway collapse. The individual motor units that make up the overall genioglossal activity typically fire with one of five patterns: active only (IP) or at higher frequency (IT) during inspiration; active only (EP) or at higher frequency during expiration (ET); and constantly active without respiratory modulation (TT). Most experimental manipulations investigated thus far (hypoxia, hypercapnia, resistive loading and sleep onset/arousal) have largely influenced IP and IT motor units, with minimal changes in units with ET, EP and TT patterns. We hypothesized that IT/IP motor units respond to respiratory drive changes, whereas TT/EP/ET motor units will respond to manipulations of the airway anatomy.

Methods

Genioglossal motor units were assessed via four intramuscular electrodes in 20 healthy individuals during wakefulness. Genioglossal single motor units were quantified before and during mandibular advancement (MAD) to 80% of maximum with a myTAP device to change airway anatomy but minimally alter respiratory drive, as well as before and during inspiratory resistive loading (IRL) of 20cmH2O/l/s for 1-minute periods.

Results

201 motor units were identified from 55 MAD trials and 234 motor units were identified from 58 IRL trials. Ventilation did not differ between baseline and MAD or IRL. The proportion of motor units with different patterns did not differ from baseline (EP=0.6%, ET=12.6%, IP=14.9%, IT=48%, TT=24%) to MAD (EP=0%, ET=10.2%, IP=21.1%, IT=36.7%, TT=31.9%), χ2(7)=12.0, p=.213. However, the proportion of motor units with different patterns differed from baseline (EP=0%, ET=15.4%, IP=34.6%, IT=32.4%, TT=17.6%) to IRL (EP=1.7%, ET=14.1%, IP=44.9%, IT=29.1%, TT=5.1%), χ2(7)=15.8, p=.0013. The peak firing frequency of motor units did not change during MAD (baseline=20.9±4.7Hz, MAD=21.9±5.4Hz) but increased during IRL (baseline=20.4±5.5, IRL=22.8±5.6Hz, p< 0.001).

Conclusion

While resistive loading increased the firing (rate and number) of inspiratory-phasic motor units as hypothesised, the firing of tonic and expiratory modulated motor units did not differ from baseline during mandibular advancement. What controls the non-respiratory/expiratory motor units of the genioglossus remains unclear.

Support (if any)

This work was funded by the Australian Research Council, DP170104375 and the Melbourne School of Psychological Sciences, University of Melbourne.
0452 C-reactive Protein Is Associated with Hypertension in Mild-to-Moderate Obstructive Sleep Apnea: Age Effect
Authors: Pejovic Slobodanka , Vgontzas Alexandros , Fernandez-Mendoza Julio , He Fan , Ellis John , Bixler Edward
Published: April 2024

Introduction

Mild-to-moderate obstructive sleep apnea (mmOSA) is highly prevalent in general population. It has been shown that mmOSA is a significant risk factor for the development of cardiovascular and cerebrovascular disease in young and middle-aged, but not in older adults. C-reactive protein (CRP) improves the ability to detect the individual risk for cardiovascular aberrations in young and middle-aged adults with mmOSA. However, it is unkown, whether CRP is also associated with hypertension risk in older patients with mmOSA.

Methods

Adults (n=208) of a wide age range (28-90 years old, mean age 52.88 ± 12.52) with mmOSA (5 ≤ AHI < 30) completed an in-lab polysomnography or home sleep testing, a physical examination including measures of blood pressure (BP) and body mass index, a structured medical history questionnaire, and a blood draw for CRP.

Results

In logistic regression models adjusting for sex and BMI, lnCRP but not AHI was associated with greater odds for hypertension (OR = 2.34, 95% CI = 1.19-4.62, p = 0.014, OR = 1.00, 95% CI = 0.93-1.09, p = 0.926 respectively). In adults ≥60 years neither lnCRP nor AHI were associated with hypertension (OR = 1.56, 95% CI = 0.78-3.11, p = 0.207 and OR = 1.02, 95% CI = 0.94-1.10, p = 0.690, respectively). Also, in adults aged < 60 years lnCRP was associated with greater average systolic (β = 0.214, p = 0.032) and diastolic BP (β = 0.230, p = 0.020) but not AHI (β = 0.026, p = 0. 826; β = 0.000, p = 0.998, respectively), while in adults ≥60 years neither lnCRP nor AHI were associated with greater systolic or diastolic BP.

Conclusion

These findings suggest that CRP is a stronger predictor of hypertension than AHI in young and middle-aged but not in older adults with mmOSA. Including a measure of CRP improves the ability for clinicians to detect cases of mmOSA at risk for hypertension in the younger group. It appears that inflammation is a primary pathogenetic mechanism in mmOSA in young and middle-aged adults but not in older ones.

Support (if any)
0453 Sleep Apnea-Specific Hypoxic Burden and Delta Heart Rate in Relation to Atrial Fibrillation in a Clinical Cohort
Authors: Heinzinger Catherine , Araujo Matheus Lima Diniz , Bena James , Thompson Nicolas , Milinovich Alex , Foldvary-Schaefer Nancy , Van Wagoner David , Chung Mina , Mehra Reena
Published: April 2024

Introduction

Mechanistic animal studies implicate intermittent hypoxia and autonomic dysfunction in the pathogenesis of obstructive sleep apnea (OSA) and atrial fibrillation (AF). Polysomnographic correlates of hypoxia and autonomic fluctuations in OSA may be useful biomarkers of AF development. However, to date, novel, reflective physiologic sleep apnea-specific hypoxic burden (SAHB) and delta heart rate (DHR) have yet to be examined in AF. We hypothesize these novel measures are associated with incident AF.

Methods

Cleveland Clinic patients (age≥18) without AF who underwent polysomnography 1/2/2000-12/30/2017 were retrospectively examined. Cox proportional hazards models evaluated time from sleep study to AF by diagnosis code. SAHB (area under the respiratory event-related desaturation curve), DHR (respiratory event-related oximetry-based heart rate difference), apnea hypopnea index (AHI), and percent time oxygen saturation< 90% (T90) were examined as predictors adjusting for age, sex, race, body mass index(BMI), tobacco use, cardiopulmonary disease, anti-arrhythmic medications, and positive airway pressure. Signal analysis used Python. Statistical analysis used R and SAS.

Results

The sample included n=15,712 patients [age 50(40,60) years, 54% female, 74% White, BMI 32(28,38) kg/m2, AHI 12.8(5.6,26.6)] over 7.3±3.2-year follow-up. In unadjusted analyses, SAHB showed monotonic increases in incident AF across quartiles(p< 0.001). In adjusted analyses, 10-unit increased SAHB was associated with 2% increased incident AF (HR=1.02,95%CI=1.01-1.03). Similarly, 10-unit increased AHI and T90 were associated with 3% (HR=1.03,95%CI=1.01-1.06) and 8% (HR=1.08,95%CI=1.05-1.11) increased AF, respectively. DHR was analyzed in a subset with available data [n=5,930, age 46(36,56) years, 52% female, 76% White, BMI 33(28,39) kg/m2, AHI 11.6(5.2,24.7)] over 6.7±.3.2-year follow-up. Low vs. mid-range DHR was associated with 39% increased incident AF (HR=1.39,95%CI=1.08-1.80), attenuated with covariate adjustment; high-range DHR did not differ.

Conclusion

In this clinical cohort, signal-based measures of OSA-specific hypoxic burden and autonomic responses were associated with increased incident AF after accounting for confounders. Findings suggest that degree of hypoxia and a dampened heart rate response are important physiologic OSA-specific AF risk factors and precision medicine phenotypes to consider for treatment responsiveness and inclusion in clinical trials.

Support (if any)

American Academy of Sleep Medicine Foundation Physician Scientist Training Grant, Cleveland Clinic Neurological Institute Center for Outcomes Research & Evaluation Pilot Grant, Neuroscience Transformative Research Resource Development Award
0455 Sleep Duration and OSA Severity Is Related to Altered Limbic System Integrity in Cognitively Normal Older Adults
Authors: Gills Joshua L , Cesar Justin Oliver , Kovbasyuk Zanetta , Dharmapuri Anhiti , McBride Julian , Valkanova Elena , Mbah Alfred , Figueredo Luisa , Kam Korey , Mullins Anna , Parekh Ankit , Jean-Louis Girardin , Varga Andrew , Osorio Ricardo , Bubu Omonigho
Published: April 2024

Introduction

Impairments in the microstructure of the limbic tracts are seen in early stages of the Alzheimer’s disease (AD) spectrum. Disrupted sleep has been linked with AD. We examined associations between measures of limbic white matter tracts and objective sleep parameters in cognitively unimpaired older adults.

Methods

This cross-sectional study included 170 community-dwelling cognitively unimpaired older adults (mean±SD: age=67.2±5.2y) participating in NYU studies of sleep, aging, and memory. Subjects completed polysomnography (NPSG) and brain MRI. Sleep measures of interest included total sleep time (TST), NREM stages 2, 3 and REM sleep duration, sleep efficiency and fragmentation, and AHI4% and REM AHI4%. Microstructural properties of the cingulum, uncinate fasciculus (UF), and fornix were estimated using diffusional tensor imaging (DTI) metrics including radial kurtosis (RK), radial diffusivity (RD), and fractional anisotropy (FA). Linear mixed-effects regression models examined associations between sleep variables and DTI metrics. Models were adjusted for age, race, education, sex, time between NPSG and MRI.

Results

Participants were 71.2% female, 44.1% Black/African-American, and had 16.8±2.5y of education. In the right cingulum, higher AHI4% in REM was associated with decreased RK(β[IV]= β[SE}; β[AHI4%] =-0.0014[0.00054], p=0.01) and shorter stage 2 sleep duration was associated with decreased RK (β [stage 2 sleep duration] =0.00062[0.00026], p=0.02). In both hemispheres of the cingulum, increased sleep fragmentation in stage 3 was associated with increased RD (β [sleep fragmentation, right] = 0.0017[0.00080], p=0.03; β [sleep fragmentation, left] = 0.0026[0.00087], p=0.003), and higher AHI4% in REM was associated with reduced FA (β [AHI4% left] =-0.00039[0.00019], p=0.048; β [AHI4% right] =-0.00055[0.00017], p=0.02). In the right UF, with increasing age, reduced TST was associated with lower RK(β[TST]=0.0000047[0.000002], p=0.02). In the right UF, reduced time in REM sleep was associated with increased RD (β [REM duration] =-0.0022[0.00078], p=0.006). In the fornix, higher AHI4% was associated with lower FA(β[AHI4%] =-0.00061[0.00029], p=0.04).

Conclusion

In this sample of community-dwelling cognitively unimpaired older adults, reduced sleep duration and OSA severity (NREM and REM) were associated with limbic white matter tracts alterations. Longitudinal studies are needed to investigate the role of disrupted sleep in limbic white matter microstructure alterations in early stages of the AD spectrum.

Support (if any)

AASM-BS-231-20, NIAK23AG068534, NIAR01AG082278, R01AG083975, AARG-D-21-848397, BrightFocus-A2022033S
0457 Altered Functional Connectivity of the Ascending Reticular Activating System in OSAS with Low Arousal Threshold
Authors: Shin Wonchul , Byun Jung-Ick , Hwang Seong-Taek
Published: April 2024

Introduction

A low arousal threshold (LAT) is a pathophysiological trait of obstructive sleep apnea (OSA) that may be associated with ascending reticular activating system (ARAS)-cortical functional connectivity (FC) changes. We evaluated resting-state FC between the brainstem ARAS nuclei and 105 cortical/subcortical regions in OSA patients with or without a LAT and healthy controls.

Methods

Twenty-five patients with moderate to severe OSA with an apnea-hypopnea index between 20 and 40/hr (15 with and 10 without a LAT) and 15 age- and sex-matched controls were evaluated. Participants underwent functional magnetic resonance imaging after overnight polysomnography. Three ARAS nuclei—the locus coeruleus (LC), laterodorsal tegmental nucleus (LDTg), and ventral tegmental area (VTA)—associated with OSA in our previous study were used as seeds.

Results

FC values of the two ARAS nuclei (LC and LDTg) significantly differed among the three groups. FC of the LC with the precuneus was stronger in OSA patients than in controls regardless of the concomitant LAT. FC between the LDTg and the posterior cingulate cortex (PCC) was also stronger in OSA patients regardless of the LAT. Moreover, OSA patients without a LAT showed stronger LDTg-PCC FC than those with a LAT (post hoc p=0.013), and this FC was negatively correlated with the minimum oxygen saturation in OSA patients (r=-0.463, p=0.023).

Conclusion

The LAT in OSA patients was associated with altered LDTg-PCC FC, which was negatively correlated with the minimum oxygen saturation. This result suggested that cholinergic activity may play a role in the LAT in OSA patients.

Support (if any)