bluuebunny/crossref_metadata_2025 huggingface dataset:
0373 Developing an Online Sleep Education Training- Lessons Learned & Future Directions
Authors: Groton Danielle , Spadola Christine , Alford Nicole
Published: May 2022

Introduction

Systems of higher education are increasingly offering online education, with the most recent expansion of e-learning surrounding the COVID-19 pandemic. As the e-learning industry grows, it provides the opporunity to expand a burgeoning body of research focusing on the development of online training to promote health across disciplines. This presentation describes the development of an interdisciplinary online training to educate social work students on sleep health and shares feedback recieved from the student experience. We describe the steps taken to develop the instructional method, content management, and the delivery of the training.

Methods

This training involved 25 collaborators across seven universities. The Center for Online and Continuing Education (COCE) at the ‘home’ institution partnered with faculty to recommend best practices in online learning and provide technical assistance. Based on formative research conducted with the target population, the training included 5 ‘modules’: introduction to sleep health, sleep hygiene, fatigue and fatigue countermeasures, sleep disorders, and sleep health among special populations. The content included mixed media, humor, and props to bolster student engagement. The COCE team created a digital ‘Sleep Health Badge’ and certificate of completion that students would earn after completing the training. The training was offered to social work students at a public university in the southeastern United States.

Results

90 students participated in the training. Students increased their sleep health knowledge, and reported being very satisfied with the structure and curriculum of the training(96.7%). Of note, while the training was only 2 hours long and asynchronous, the the most frequent recommended change given by participants was to shorten the length of the videos (20.8% of responses).

Conclusion

Overall, the training was well-received and is in the process of being adapted for professional social workers. For future development of online trainings, we will share reflections and recommendations as they relate to each of the major components of e-learning: content development, instructional method, content management, and content delivery/presentation. We center these reflections around both student feedback on the online training, and our own experiences in developing this training.

Support (If Any)

American Academy of Sleep Medicine Foundation
0376 Evaluation of healthcare delivery disparities among the Native American population: Knowledge and Attitudes of obstructive sleep apnea among the Indian Health Services primary care physicians
Authors: Rihawi Anas , Tah Sumeer , Rangan Pooja , Knobbe Kirstin , Lee-Iannotti Joyce
Published: May 2022

Introduction

The burden of racial disparities in diagnosis and treatment of Obstructive sleep apnea (OSA) remains underrecognized among the Native American population. This study intends to assess the knowledge and attitudes towards diagnosis and management of obstructive sleep apnea among the primary care physicians caring for the Native American population.

Methods

A cross-sectional survey was conducted at an Indian Health Services (IHS) primary care clinic. A validated OSA Knowledge (18 questions) and Attitudes (5 questions) (OSAKA) questionnaire was used, in addition to one question to address referrals to a sleep specialist.

Results

A total of 20 primary care providers were invited to participate in the survey with a response rate of 45% (9 participants, 2 males and 7 females). The median (IQR) knowledge score was 14 (13-16). The mean (±SD) percentage of correct response (proportion of correctly answered questions) was 79% (±9.5), which was similar to previously reported scores among primary care physicians in other studies. There was no significant knowledge difference between males and females and no difference based on age. All participants felt it was very or extremely important to identify patients with OSA and that OSA is important as a clinical disorder. There was a significant positive correlation between knowledge and recognizing the importance of OSA as clinical disorder, and between knowledge and confidence in identification of OSA. There was a negative correlation between confidence in OSA identification and referral to a sleep specialist but was not statistically significant. Only one participant (11%) felt comfortable managing patients on CPAP therapy, but there was no significant correlation with referrals to a sleep specialist.

Conclusion

Obstructive sleep apnea knowledge in IHS primary care providers is comparable to their peers. However, the lack of comfort in managing patients with OSA on CPAP did not increase referrals to a sleep specialist. This highlights a possible disparity and resource gap in treating Native Americans within the IHS health system with sleep apnea and further studies are needed.

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0394 Efficacy and Safety in People With Narcolepsy Transitioning From Sodium Oxybate to Lower-Sodium Oxybate: Data From the Real-World TENOR Study
Authors: Leary Eileen , Zee Phyllis , Fuller Douglas , Macfadden Wayne , Steininger Teresa , Bae Charles , Husain Aatif
Published: May 2022

Introduction

Lower-sodium oxybate (LXB) contains 92% less sodium than sodium oxybate (SXB) and is approved for treating cataplexy or excessive daytime sleepiness in patients with narcolepsy (aged ≥7 years) and idiopathic hypersomnia in adults. The Transition Experience of persons with Narcolepsy taking Oxybate in the Real-world (TENOR) study collects data from patients transitioning from SXB to LXB in a real-world setting.

Methods

TENOR is a patient-centric, prospective, observational, noninterventional, virtual-format study (NCT04803786). Eligible participants include US adults with confirmed narcolepsy (type 1 or 2) transitioning from SXB to LXB within the previous/upcoming 7 days. Longitudinal data are collected for 21 weeks post-transition. Efficacy measures (Epworth Sleepiness Scale [ESS]; Functional Outcomes of Sleep Questionnaire, Short Version [FOSQ-10]; and British Columbia Cognitive Complaint Inventory [BC-CCI]) are collected at baseline (taking SXB) and weekly beginning at week 1 (taking LXB). Participants were prospectively queried about changes in tolerability. These analyses include data collected during the first week of LXB from all qualifying participants.

Results

The analyses include 85 participants (type 1, n=45; type 2, n=40) at baseline and 79 participants at week 1. At baseline, mean (SD) age was 40.3 (13.0) years; most participants were female (73%) and White (87%), and 79% took ≥1 concomitant medication for narcolepsy at baseline in addition to SXB. Patient-reported comorbidities included depression (54%), anxiety (46%), obstructive sleep apnea (27%), and hypertension (24%). At baseline (taking SXB) and week 1 (taking LXB), mean (SD) ESS scores were 9.9 (5.2) and 9.7 (5.2), respectively (mean [SD] change: −0.3 [2.7]); mean (SD) FOSQ-10 scores were 28.7 (7.1) and 28.8 (7.5), respectively (mean [SD] change: 0.2 [3.9]); and mean (SD) BC-CCI scores were 6.1 (4.4) and 6.1 (4.7), respectively (mean [SD] change: 0.0 [2.3]). Tolerability associated with LXB treatment was consistent with the known safety profile of SXB.

Conclusion

In this real-world study in people with narcolepsy who are transitioning from SXB to LXB, efficacy of oxybate treatment on measures of excessive daytime sleepiness, quality of life, and cognition as well as safety were maintained after 1 week. Longer-term maintenance of efficacy and safety will be reported at study completion.

Support (If Any)

Jazz Pharmaceuticals.
0397 Autonomic Reflex Testing Confirms Autonomic Disturbances in a Cohort of Patients with Idiopathic Hypersomnia
Authors: Aviv Rachel , Zitser Jennifer , Miglis Mitchell , Chiaro Giacomo , Guaraldi Pietro
Published: May 2022

Introduction

Symptoms suggestive of autonomic nervous system (ANS) dysfunction have been previously described in patients with idiopathic hypersomnia (IH), however, objective ANS reflex testing data has not been reported. We aimed to better quantify symptoms of ANS dysfunction in a cohort of patients with IH through the use of standardized ANS reflex testing.

Methods

Patients diagnosed with IH based on ICSD-3 criteria using overnight video polysomnography and multiple sleep latency testing (MSLT) were consecutively enrolled in our study, regardless of ANS symptoms. All patients underwent ANS reflex testing, including measures of parasympathetic (heart rate variability with deep breathing and Valsalva ratio) and sympathetic adrenergic function (Valsalva blood pressure response and 10-minute head-up tilt at an angle of 70 degrees) with continuous blood pressure and heart rate monitoring. Eleven patients also underwent measures of sympathetic cholinergic function (quantitative sudomotor axon reflex testing). All medications that affect ANS function were held prior to ANS testing, including wake-promoting medications and sodium oxybate.

Results

Twenty patients with IH were enrolled. Fifty percent (10/20) were long sleepers (>11hrs). Mean sleep onset latency and number of sleep onset REM periods (SOREMs) on MSLT were 6.9 (± 3.1) mins and 0.2 (± 0.4), respectively. Mean duration of IH symptoms prior to the date of ANS testing was 6.3 (± 8.1) yrs. Eighty-five percent (17/20) of patients had abnormal ANS testing. Of these, 75% (15/20) had sympathetic adrenergic impairment, 64% (7/11) had sympathetic cholinergic impairment, and 5% (1/20) had parasympathetic impairment. Fifty-five percent (11/20) of patients were diagnosed with postural tachycardia syndrome (POTS), 45% (5/11) with small fiber neuropathy, 5% (1/20) with inappropriate sinus tachycardia and 15% (3/20) with neurally-mediated syncope. Seventy percent (14/20) of patients reported orthostatic intolerance regardless of autonomic diagnosis.

Conclusion

ANS dysfunction was common and severe in our cohort of IH patients, affecting all domains of ANS reflex testing, with more prominent impairment in sympathetic domains. POTS was the most common comorbid diagnosis, and most patients reported orthostatic intolerance. There was no association with IH disease duration, though our sample size was limited. Future studies will focus on ANS testing in larger cohorts of IH patients, specifically on shared pathophysiological mechanisms of hypersomnia and ANS dysfunction.

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0403 Efficacy of Once-nightly Sodium Oxybate (ON-SXB; FT218) for Excessive Daytime Sleepiness and Cataplexy: Post-hoc Number Needed to Treat and Effect Size Analyses From REST-ON
Authors: Thorpy Michael , Roth Thomas , Kushida Clete , Seiden David , Dubow Jordan , Gudeman Jennifer
Published: May 2022

Introduction

FT218 is an investigational, extended-release, once-nightly formulation of sodium oxybate (ON-SXB) for adults with narcolepsy. ON-SXB treatment achieved significant improvement vs placebo (6 g, 7.5 g, and 9 g, all P<0.001) for the coprimary endpoints of mean sleep latency on the Maintenance of Wakefulness test (MWT), Clinical Global Impression of Improvement rating, and number of weekly cataplexy episodes (NCA), and the secondary endpoint Epworth sleepiness scale (ESS) score, in the phase 3 REST-ON trial (NCT02720744). Post-hoc analyses of numbers needed to treat (NNT) and effect sizes were performed to further contextualize the effectiveness of ON-SXB.

Methods

Participants in REST-ON (aged ≥16 years with narcolepsy type 1 or 2) were randomized 1:1 to receive ON-SXB (1 week, 4.5 g; 2 weeks, 6 g; 5 weeks, 7.5 g; 5 weeks, 9 g) or placebo. MWT response was defined as ≥5-min increase from baseline in mean sleep latency, ESS response as a score ≤10, and cataplexy response as ≥50% reduction from baseline in mean NCA. Effect sizes were calculated using Cohen’s d; NNTs were the inverse of the absolute risk reduction.

Results

The modified intent-to-treat population included 190 participants (ON-SXB, n=97 [NT1, n=73]; placebo, n=93 [NT1, n= 72]). For MWT response, all ON-SXB doses (6 g at week 3, 7.5 g at week 8, and 9 g at week 13) had NNTs of 3 and effect sizes of 0.7–0.9. A dose-response effect was seen for ESS response with NNTs ranging from 3 to 6. Effect sizes were between –0.5 to –0.7 for the 3 doses (decreases signifying response). The NNT for cataplexy response was 6 for ON-SXB 6 g and 3 for ON-SXB 7.5 and 9 g; effect sizes were between –0.7 to –0.8.

Conclusion

NNT calculations show that 3–6 patients need to be treated with ON-SXB to achieve ≥5 minutes increased sleep latency on the MWT, ESS score ≤10, or a ≥50% reduction in cataplexy. Considering these post-hoc analyses may be useful to clinicians in discussing treatment expectations and provide support for the efficacy of ON-SXB for excessive daytime sleepiness and cataplexy in adults with narcolepsy.NNT calculations show that 3–6 patients need to be treated with ON-SXB to achieve ≥5 minutes increased sleep latency on the MWT, ESS score ≤10, or a ≥50% reduction in cataplexy. Considering these post-hoc analyses may be useful to clinicians in discussing treatment expectations and provide support for the efficacy of ON-SXB for excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Support (If Any)

Avadel Pharmaceuticals
0404 Patient and Provider Preferences for Oxybate Treatment for Narcolepsy: A Discrete Choice Experiment
Authors: Morse Anne Marie , Krahn Lois , Kushida Clete , Thorpy Michael , Flygare Julie , Seiden David , Athavale Amod , Gudeman Jennifer
Published: May 2022

Introduction

Currently available immediate-release sodium oxybate (SXB) and mixed-salt oxybates are dosed twice nightly (second 2.5–4 hours after first). Extended-release, once-nightly SXB (ON-SXB; FT218) is in development. To characterize drivers of oxybate treatment attribute preferences, discrete choice experiments (DCEs) were conducted for both patients and healthcare providers (HCPs).

Methods

Thirty-minute web-based surveys were fielded to 1) adults with self-reported physician-diagnosed narcolepsy with/without prior/current use of oxybate, and 2) board-certified/board-eligible HCPs treating ≥5 narcolepsy patients in the last month. Choice sets of 2 hypothetical treatment profiles were generated combining attributes of twice-nightly SXB, mixed-salts oxybate, and ON-SXB. While viewing 12 choice sets, each participant indicated (1) their preferred product overall, (2) the product that would improve quality of life (QoL), and (3) the product that would result in less patient stress/anxiety. Results were analyzed using a mixed logit model.

Results

For patients (n=120) and HCPs (n=100), the most important attribute driving overall product choice was dosing frequency (relative attribute importance, 26.0 and 46.1, respectively), with once-nightly preferred over twice-nightly dosing (relative preference weight, ±25.6 and ±43.6); QoL (relative attribute importance, 28.7 and 41.7), with once-nightly preferred over twice-nightly dosing (relative preference weight, ±25.7 and ±38.5); and reducing patient anxiety/stress (relative attribute importance, 26.7 and 44.0), with once-nightly preferred over twice-nightly dosing (relative preference weight, ±23.9 and ±41.6). Other drivers of overall product choice were as follows: patients, clinical efficacy and sodium content (relative attribute importance, 23.5 and 20.8); HCPs, adverse reactions and sodium content (relative attribute importance, 19.7 and 18.6). Drivers of QoL preference were as follows: patients, clinical efficacy and sodium content (relative attribute importance, 28.3 and 20.9); HCPs, adverse reactions and clinical efficacy (relative attribute importance, 21.5 and 18.6). Drivers of reducing patient anxiety/stress were as follows: patients, clinical efficacy and sodium content (relative attribute importance, 17.4 and 17.3); HCPs, adverse reactions and sodium content (relative attribute importance, 18.2 and 14.2).

Conclusion

Dosing frequency was identified as the most important attribute driving preference for overall product choice, QoL, and reducing patient anxiety/stress for both patients and HCPs with once-nightly preferred over twice-nightly dosing.

Support (If Any)

Avadel Pharmaceuticals
0405 Patient and Healthcare Provider Surveys of Narcolepsy Disease Burden and Oxybate Treatment Experience
Authors: Morse Anne Marie , Krahn Lois , Kushida Clete , Thorpy Michael , Flygare Julie , Seiden David , Athaval Amod , Gudeman Jennifer
Published: May 2022

Introduction

Immediate-release sodium oxybate (SXB) and mixed-salt oxybates require patients with narcolepsy to take a second nightly dose 2.5–4 h after the first. Extended-release, once-nightly SXB (ON-SXB; FT218) is an investigational treatment for adults with narcolepsy. Surveys evaluated patient and healthcare provider (HCP) perspectives on narcolepsy disease burden and satisfaction with current narcolepsy treatment options.

Methods

Individuals with narcolepsy and HCPs participated in 30-minute, web-based surveys. Participants were 1) adults with self-reported, physician-diagnosed narcolepsy for ≥1 year, and prior/current/no use immediate-release oxybates; and 2) board-certified/board-eligible HCPs (pulmonology, sleep medicine, neurology, psychiatry specialties); nurse practitioners; or physician assistants. Participants responded using 9-point scales; higher scores indicated greater severity/agreement/satisfaction/importance/preference.

Results

Mean patient participant (n=120) age was 40 years; most were white (81%), female (79%), and current/past users of twice-nightly SXB (n=86) or mixed-salt oxybates (n=56). Twenty-six were oxybate naive. Most HCPs (n=100; 68% male) had sleep medicine (37%) or neurology (30%) specialties; 91% and 83% had experience with twice-nightly SXB and mixed-salt oxybates, respectively. Patients and HCPs agreed that patients preferred narcolepsy treatments dosed fewer times (rated 6.7 and 7.7, respectively). Common symptoms patients experienced daily/almost daily at narcolepsy diagnosis were tiredness/fatigue (64%) and excessive daytime sleepiness (EDS; 68%). HCPs and patients expressed moderate-to-high satisfaction with mixed-salt oxybates (both 7.1) and twice-nightly SXB (6.8 and 6.6, respectively). Compared to HCPs, patients were less satisfied with modafinil (6.9 vs 4.5), armodafinil (6.9 vs 4.8), solriamfetol (6.8 vs 5.4), and pitolisant (6.6 vs 5.2). Twice-nightly SXB and mixed-salt oxybates received high ratings from patients and HCPs for reduction of cataplexy (patients: 7.3 and 7.4; HCPs, 6.7 and 6.8) and EDS (patients: both 7.0; HCPs, both 6.9). Lower satisfaction was reported for twice-nightly SXB and mixed-salt oxybates with dosing frequency (patients, 5.4 and 6.0; HCPs, 5.9 and 6.3) and medication taste (patients, 5.3 and 5.7; HCPs, 5.9 and 6.2).

Conclusion

While both individuals with narcolepsy and HCPs are relatively satisfied with current narcolepsy treatments, both groups are less satisfied with the dosing frequency of currently approved oxybate formulations. ON-SXB will be an additional treatment option that can address this unmet need.

Support (If Any)

Avadel Pharmaceuticals
0409 Self-perceived sleep during the Maintenance of Wakefulness Test: how does it predict accidental risk in patients with sleep disorders?
Authors: Philip Pierre , Micoulaud-Franchi Jean-Arthur , Bioulac Stéphanie , Taillard Jacques , Guichard Kelly , Dauvilliers Yves , Bastien Célyne , Sagaspe Patricia
Published: May 2022

Introduction

The objective of this study is to determine whether the feeling of having slept or not during the Maintenance of Wakefulness Test (MWT) is associated with the occurrence of self-reported sleep-related traffic near misses and accidents in patients with sleep disorders.

Methods

This study was conducted in patients hospitalized in a French sleep center to perform a 4 × 40 min MWT. Relationship between mean sleep latency on the MWT, feeling of having slept or not during MWT trials and sleep-related near misses and accidents reported during the past year was analyzed.

Results

One hundred and ninety-two patients suffering from OSAS, idiopathic hypersomnia, narcolepsy, restless leg syndrome or insufficient sleep syndrome were included. One hundred and sixty-five patients presented no or one misjudgment of feeling of having slept during MWT trials while 27 presented more than two misjudgments. Almost half of the latter (48.1%) reported a sleepiness-related traffic near miss or accident in the past year versus only one third (27.9%) for the former (p < 0.05). Multivariate logistic regression showed that patients with more than two misjudgments had a 2.52-fold (95% CI, 1.07–5.95, p < 0.05) increase in the risk of reporting a sleepiness-related near miss/accident.

Conclusion

Misjudgment in self-perceived sleep during the MWT is associated with the occurrence of self-reported sleepiness-related traffic near misses and accidents in the past year in patients suffering from sleep disorders. Asking about the perception of the occurrence of sleep during the MWT could be used to improve driving risk assessment in addition to sleep latencies.

Support (If Any)

This was not an industry supported study. This project was supported by a grant from the French Sleep Society (SFRMS).
0421 The pupillary light reflex detects hyperarousal and discriminates between adults with nil versus modest insomnia symptoms
Authors: McCall William
Published: May 2022

Introduction

Physiologic and psychologic hyperarousal is a leading candidate mechanism behind insomnia symptoms. Increased levels of physiologic arousal have been demonstrated in insomnia patients versus healthy sleepers using a variety of methods including brain PET, Multiple Sleep Latency Testing, ambulatory core body temperature, and sympathetic nerve microneurography. All of these methods, however, are expensive, or technologically intensive, or invasive. In contrast, the pupillary light reflex (PLR) is comparatively inexpensive, portable, easy to measure, and well-tolerated by patients. The average constriction velocity (ACV) in response to a controlled light stimulus is an indicator of physiologic arousal, with more rapid constriction indicating greater arousal.

Methods

Forty community volunteers provided informed written consent to measurement of their PLR after a period of dark adaptation with the NeurOptics PLRTM-3000 Pupillometer (Laguna Hills, CA), which continuously measures pupil size to a precision of 0.1 mm, at a frequency of 30 Hz. None of the participants were seeking or receiving mental health services, were taking psychotropics, or were using any prescribed or over the counter medication that might affect the PLR. Participants also completed the Patient Health Questionnaire-9 (PHQ-9) and the Insomnia Severity Index (ISI). The protocol was approved by the local IRB.

Results

Sixteen of the volunteers had an ISI score > 4 (“modest ISI”), and 24 had an ISI score < 4 (nil ISI). The overall sample was 26.4 + 9.1 years old, 62.5% female, and 30% non-white, with no significant differences between the ISI score groups. The “nil ISI” and “modest ISI” groups had ISI scores of 1.2 + 1.3 versus 8.7 + 3.6 (p<0.001), PHQ-9 scores of 1.5 + 1.3 versus 5.4 + 4.4 (p<0.005), and ACV of -2.7 + 0.6 versus -3.1 + 0.5 mm/sec (p<0.05), respectively.

Conclusion

This small study of community volunteers showed PLR evidence of relative hyperarousal in those participants with modest levels of insomnia symptoms. With further development, the PLR may have promise in practical identification of a “hyperarousal subtype” of insomnia patients.

Support (If Any)

None
0422 Insufficient sleep in undergraduate students: an intervention based on a systematic literature review
Authors: Pavoni Mariana , Lopes Maria-Cecilia , Cysneiros Laura , Gutierres Gabriela , Silva Elizabeth Araujo e , Braga Victor , Salmazo Henrique
Published: May 2022

Introduction

Sleep is essencial to health, and to the performance of daily activities, and mood, memory, attention, and cognitive processes.

Methods

We systematically reviewed the literature about the sleep in undergratuate students from 2019 to 2020, also we applied a semi-structured questionnaire in 300 undergrate students between 18-24 years of age. Sixteen studies met inclusion criteria in databases: MEDLINE/PUBMED, SCIELO and LILACS on circadian cycle disorders and daytime sleepiness in undergraduate students. The descritptors were applied in order to delimit the articles in the objectives of this study: sleep, undergrade students, daytime sleepiness and circadian cycle disorders. We applyed on-probabilistic sampling technique using Health Educional Content Validation instrument that was composed by 15 items to analyse sleep habbits in undergratuate students.

Results

7591 scientific articles were analyzed, and only 38 were submitted to the application of the PICOS strategy. We included 16 articles in this systematic literate review sample. The studies have shown that the quality of sleep in these students was straongly impaired by stress, depression, family income and behavioral variables. The answers from the Goggle forms analyses with 76.3% of excessive daytime sleepiness, in the area of the questionnaire used a scale from 1 to 5 (where 1 was very little in order to score peculiarities related to the students habits in relation to a routine that values Sleep Hygiene. Fixed times for waking up on weekdays (96, 6%), and only 24.4% of the sample had a fixed time to sleep on weekends. More than 150 students (53.2%) made no effort to stay away from the screen before sleeping. The distribution of responses showed that an average number of people try to avoid using the bed to work or watch television (73.9%) and try to avoid heavy foods before bed (83.1%). We found that the consequences of insufficient sleep, such as insomnia and daytime sleepiness were prevalente in females, and among students who didn’t practice sleep hygiene, were colays and falling asleep during class, twice the risk of depression and headache.

Conclusion

The prevalence of sleep disorders among undergraduated students needs to be evalute, preventing the harmful consequences in their cognitive decisions.

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0423 Associations of individual behaviors and ambient factors in the sleep environment with nighttime sleep parameters in pregnant women with insomnia
Authors: Badon Sylvia , Manber Rachel , Simpson Norah
Published: May 2022

Introduction

Sleep hygiene and environment are important for adequate sleep quantity and quality. We examined two aspects of the sleep environment, individual behaviors and ambient factors, with nighttime sleep parameters in pregnant women with insomnia.

Methods

We used baseline data from a randomized controlled trial of insomnia treatment during pregnancy for this cross-sectional analysis (n=70). Women completed a questionnaire assessing whether they regularly engaged in five individual behaviors in bed (yes/no) and how much their sleep was disrupted by seven ambient factors (scale from 1=not very much to 5=very much) and wore an Actiwatch 2 for a subsequent 7-day period. Responses of 4 or 5 for ambient factor items were categorized as ambient factors perceived to disrupt sleep. Generalized estimating equation regression models were used to estimate associations of individuals behaviors and ambient factors perceived to disrupt sleep with actigraphy-measured total nighttime sleep duration and sleep efficiency.

Results

The most commonly endorsed individual behaviors were using the internet/computer in bed (64%) and watching television in bed (43%), followed by talking on the phone in bed, listening to music in bed, and playing video/electronic games in bed (16-27%). Watching television in bed was associated with 23 fewer minutes of actigraphy-measured nighttime sleep (95% CI: -44, -1). No individual behavior was associated with actigraphy-measured sleep efficiency (all P>0.05). The most commonly endorsed ambient factors perceived to disrupt sleep were environmental noise (41%) and uncomfortable temperature (37%), followed by movement from others sharing the bed, having to take care of children in the middle of the night, someone else snoring, and light (24-29%). No ambient factors perceived to disrupt sleep were associated with actigraphy-measured nighttime sleep duration or efficiency (all P >0.05).

Conclusion

Individual behaviors and ambient factors perceived to disrupt sleep were common in pregnant women with insomnia. In this study, only watching television in bed was associated with objectively-measured nighttime sleep duration. Our findings suggest that future research could investigate potential interfering roles of arousal and cognitive factors contributing to insomnia during pregnancy.

Support (If Any)

National Institutes of Health (K99HD100585, R01NR013662)
0424 Influence of daytime napping on the discrepancy between subjective and objective nighttime sleep measures in pregnant women with insomnia
Authors: Badon Sylvia , Dietch Jessica , Gumport Nicole , Simpson Norah , Manber Rachel
Published: May 2022

Introduction

Previous research has documented a tendency among adults with insomnia to underestimate nighttime sleep duration compared to actigraphy estimates. We examined whether discrepancy in nighttime sleep parameters is impacted by daytime napping behavior.

Methods

We used baseline data from a randomized controlled trial of insomnia treatment during pregnancy for this cross-sectional analysis (n=97). Women self-reported daytime napping and nighttime sleep characteristics using a 7-day sleep diary and wore an Actiwatch 2 during the same 7-day period. Two women napped daily and were excluded from this analysis. The remaining sample was categorized as intermittent nappers [naps on some but not all days; n=62 (65%)] or non-nappers [no naps on any days; n=33 (35%)]. We summarized daily discrepancy between self-reported and actigraphy-measured nighttime sleep duration and efficiency by daytime napping behavior using means and t-tests.

Results

Intermittent nappers provided data for 130 days with naps and 260 days without naps. Non-nappers provided data for 198 days. Among intermittent nappers, there was no meaningful subjective-objective discrepancy for nighttime sleep duration or efficiency (mean discrepancy=1 minute for duration; -0.4% for efficiency); this did not differ between days with naps and days without naps (p=0.98 for sleep duration; p=0.33 for sleep efficiency). Among non-nappers, subjective-objective discrepancy was present (intermittent nappers vs non-nappers p=0.001 for duration; p=0.04 for efficiency), with self-report underestimating actigraphy-measured nighttime sleep duration by 28 minutes and nighttime sleep efficiency by 3.5%.

Conclusion

Pregnant women with insomnia who did not nap tended to underestimate nighttime sleep duration and efficiency compared to actigraphy measurement, as has been reported in the general population of adults with insomnia. However, there was no meaningful subjective-objective discrepancy for nighttime sleep duration and efficiency among those who napped intermittently, regardless of that day’s napping behavior. It is possible that daytime napping impacts overall accuracy of perceived nighttime sleep. However, because some people with insomnia are unable to nap even when given the opportunity, it is possible that not napping and sleep discrepancy share a common underlying cause. Future research is needed to test if results replicate to non-pregnant populations and explore mechanisms that may explain these findings.

Support (If Any)

National Institutes of Health (K99HD100585, R01NR013662)
0426 Shallower sleep depth in the laboratory is not related to insomnia severity
Authors: Larson Olivia , Younes Magdy , Weljie Aalim , Sengupta Arjun , Gehrman Philip
Published: May 2022

Introduction

In insomnia, classical sleep scoring parameters are often uncorrelated with symptom severity and may not fully capture more subtle alterations in the polysomnogram (PSG) that could contribute to clinical symptoms. The odds ratio product (ORP) is a well-validated, continuous index of sleep depth (range 0=deep sleep; 2.5=full wakefulness) that offers an alternative to traditional staging. It is unknown whether ORP is related to self-reported insomnia severity. We hypothesized that individuals with insomnia would exhibit higher ORP values than healthy controls (reflecting less deep sleep) which would be associated with greater insomnia severity.

Methods

This is a secondary analysis of data from a study in which n=15 participants with chronic insomnia disorder and n=15 age- and sex-matched healthy controls completed an in-laboratory protocol (N=30; 66% female; 36±8 years; 63% White). Participants had their sleep monitored with in-lab PSG. The Insomnia Severity Index (ISI) was used to estimate sleep disturbance severity. PSG were used to calculate classical sleep scoring parameters as well as the average ORP in each sleep stage. Independent samples t-tests compared means between the insomnia and healthy control groups and Pearson’s correlations assessed relations between PSG/ORP outcome measures and ISI scores.

Results

The insomnia group’s mean (SD) ISI score was 14.13 (6.00) and significantly higher than the control group’s (1.73 (2.37); corrected p < 0.001). There were no statistically significant between-group differences for classically-scored sleep parameters or average ORP values after correcting for multiple comparisons. Interestingly, means for the insomnia group’s average ORP values tended to be higher than those of the control group’s. ISI scores were not significantly associated with average ORP values across or within groups.

Conclusion

Insomnia does not appear to be associated with alterations in global sleep depth when measured in a laboratory setting, but there is a need to conduct more detailed analyses on patterns across the night.

Support (If Any)

Merck, Inc. Investigator Studies Program
0430 Beyond symptoms: Using the Cost of Insomnia Checklist to Characterize the Subjective Burden of Insomnia
Authors: Glidewell Robert , Gallegos Taela , Okun Michele
Published: May 2022

Introduction

Traditional symptom focused assessments do not characterize the subjective impact of insomnia on patient's function and quality of life (QOL). The authors developed the Cost of Insomnia Checklist (CIC) to evaluate the effects of insomnia in the life domains most meaningful to patients. In bringing attention and awareness to these areas, such a tool may increase patient motivation to look for, initiate, and or persist in treatment. It may also help overcome habituation effects that lead patients to minimize the seriousness of insomnia.

Methods

The CIC has 68 items across seven categories (financial; health; family; cognition; mental and emotional; work; social and recreational). We developed CIC items based on clinical interviews with chronic insomnia patients in a behavioral sleep medicine clinic. Ninety-five patients completed the CIC during their clinical evaluation for chronic insomnia.

Results

Participants were 53% female, 81% white, 57% employed, 56% married, and 23% living alone with a mean age of 50.48 (+/- 16.03) and mean BMI of 24.91 (+/-5.29). Patients endorsed an average of 21.9 (SD 33.9; Median=21) items with a range of 4 to 52 items. The most often endorsed items (>70%) focused on not feeling rested, worry about sleep, daytime sleepiness and fatigue, and memory and attention problems. 97% of respondents endorsed one or more additional items. The most frequently endorsed additional items were “can't maintain energy level” (69.5%), “too tired to exercise” (57.9%), “discomfort of sleeplessness” (56.8%), “irritable/unkind to others” (55.8%), “can't think of the words I want to use” (54.7%), “unmotivated/uninterested” (54.7%), “daytime discomfort after a bad night” (53.7%), “stressed without good reason” (52.6%), “worry about daytime function” (51.6%), “news/doctors tell me Insomnia is bad for me” (50.5%).

Conclusion

The CIC evaluates the effect of insomnia in many life domains and may help patients recognize the impact of insomnia on daytime function and QOL. Future studies will measure how the CIC correlates with treatment participation, adherence, and outcomes. Future studies will also support revision of the CIC to keep only items not measured by other instruments.

Support (If Any)

None
0451 Effect of Lemborexant Treatment on Polysomnographic Sleep Measures in Older Adults with Insomnia and Objective Short Sleep
Authors: Krystal Andrew , Edinger Jack , Kumar Dinesh , Pappadopulos Elizabeth , Malhotra Manoj , Moline Margaret
Published: May 2022

Introduction

In Phase 3 Study 304 (NCT02783729), lemborexant (LEM) provided significant benefit versus placebo (PBO) on polysomnographic (PSG) and sleep diary-based sleep onset and maintenance outcomes over 1mo in subjects with insomnia disorder. Based on evidence that patients with insomnia and objective short sleep (ISS [total sleep time; TST] <6hrs) may respond less well to interventions such as cognitive behavioral therapy for insomnia (CBT-I) than patients with insomnia and objective long sleep (TST ≥6hrs), we conducted post-hoc analyses of LEM efficacy in the ISS subgroup (subjects with PSG TST<6hrs).

Methods

Study 304 was a 1mo, randomized, double-blind, PBO- and active-controlled, parallel-group study in female (age ≥55y) and male (age ≥65y) subjects (n=1006). Subjects received PBO, LEM 5mg (LEM5), LEM 10mg (LEM10), or zolpidem tartrate extended-release 6.25mg (ZOL). Latency to persistent sleep (LPS) and wake after sleep onset (WASO) were assessed at Nights (NT) 1/2 and NT29/30 using PSG and averaged; change from baseline (paired PSGs during single-blind PBO run-in) were analyzed using mixed-effect model repeated measurement analysis.

Results

The ISS subgroup comprised 710/1006 (70.58%) subjects. Mean (SD) baseline LPS was similar across treatments: PBO=52.80(35.73); ZOL=54.77(40.93); LEM5=54.28(39.30); LEM10=53.31(34.45). On NT1/2, LEM5/10 led to statistically significantly greater (P<0.05) decreases from baseline (PBO=−9.65[36.52]; ZOL=−17.78[36.34]; LEM5=−22.02[31.62]; LEM10=−25.42[34.73]) versus PBO and ZOL. On NT29/30, LEM5/10 led to statistically significantly greater (P<0.0005) decreases from baseline (PBO=−11.88[35.09]; ZOL=−12.57[38.50]; LEM5=−25.37[37.06]; LEM10=−28.20[34.75] versus PBO. ZOL was not different from PBO. Mean (SD) baseline WASO was similar: PBO=123.79(37.21); ZOL=128.37(38.94); LEM5=128.14(37.52); LEM10=129.07(37.98). On NT1/2, LEM5/10 led to statistically significantly greater (P<0.0001) decreases from baseline (LSM[SE]: PBO=−23.52[2.74]; ZOL=−54.74[2.47]; LEM5=−60.58[2.45]; LEM10=−69.35[2.41] versus PBO. LEM10 was significantly different than ZOL (P<0.0001). On NT29/30, LEM5/10 led to statistically significantly greater (P<0.0001) decreases from baseline (PBO=−29.62[3.09]; ZOL=−46.86[2.80]; LEM5=−52.67[2.74]; LEM10=−55.37[2.70] versus PBO. LEM10 was significantly different than ZOL (P<0.05).

Conclusion

The data support LEM as an effective therapy for older adult patients with ISS and suggest LEM may be more beneficial than ZOL, particularly for patients with ISS and sleep onset difficulties. These findings suggest that LEM may be a reasonable therapy to consider for treating older patients with ISS where CBT-I may have relatively limited efficacy.

Support (If Any)

Eisai Inc.
0452 Lemborexant Treatment of Older Adults with Insomnia and Objective Short Sleep: Rates of Response and Remission
Authors: Edinger Jack , Krystal Andrew , Kumar Dinesh , Pappadopulos Elizabeth , Lundwall Christie , Moline Margaret
Published: May 2022

Introduction

In Phase 3 Study 304 (NCT02783729), lemborexant (LEM) provided significant benefit versus placebo (PBO) on polysomnographic (PSG) endpoints and sleep diary-based sleep onset and maintenance outcomes over 1mo in subjects with insomnia disorder. The study also included the Insomnia Severity Index (ISI) to ensure sufficient insomnia severity at baseline (ISI total score ≥13) and for use as an outcome measure. Subjects met criteria for insomnia disorder and were confirmed to spend between 7-9 hours in bed. Subjects had insomnia with objective short sleep (ISS; [total sleep time; TST] <6hrs) or objective long sleep (TST ≥6hrs). Since patients with ISS may respond less well to therapeutic approaches such as cognitive behavioral therapy for insomnia (CBT-I), we examined rates of response and remission with LEM as defined by the ISI in the ISS subgroup.

Methods

Study 304 was a 1mo, randomized, double-blind, PBO- and active-controlled, parallel-group study in female (age ≥55y) and male (age ≥65y) subjects (n=1006). Subjects received PBO, LEM 5mg (LEM5), LEM 10mg (LEM10), or zolpidem tartrate extended-release 6.25 mg (not reported). Baseline PSGs were obtained during a single-blind PBO run-in, followed by paired PSGs on Nights 1/2 and Nights 29/30. The ISI was given at baseline and end of treatment. For these post-hoc analyses, responders were defined as subjects whose decrease from baseline on the ISI was ≥7pts, while remitters achieved ISI total scores <8pts. LEM5 and LEM10 vs PBO differences were evaluated using chi-square tests.

Results

525/743 (70.66%) of subjects in the PBO/LEM groups were in the ISS subgroup. For LEM5, 99/176 (56.25%) were responders and 49/176 (27.84%) were remitters. For LEM10, 97/180 (53.89%) were responders and 50/180 (27.78%) were remitters. For the PBO group, 59/140 (42.14%) were responders and 21/140 (15.00%) were remitters. The responder and remitter rates for LEM5 and LEM10 were statistically significantly greater than those for PBO (all P<0.05).

Conclusion

Older adults with ISS achieved clinically meaningful improvement with LEM as assessed at the end of one month of treatment, with nearly 30% considered remitters and >50% considered treatment responders. LEM is a potential therapy for ISS patients who may have limited response to CBT-I.

Support (If Any)

Eisai Inc.
0462 Baseline Sleep Disturbance and Inability to Discontinue Chronic Hypnotic Use
Authors: Koshorek Gail , Parashar Vartika , Roth Thomas , Roehrs Timothy
Published: May 2022

Introduction

Clinicians prescribing hypnotics remain concerned regarding the inability to discontinue hypnotics after chronic use, which has never been directly tested in a controlled prospective study using self-administration choice methodology. This study reports on difficulty discontinuing medication as a function of basal sleep disturbance in insomnia subjects instructed to stop taking their study medication after 6 months of nightly use.

Methods

DSM-V diagnosed insomnia subjects, aged 23-61 yrs, (n=39, 34 females), with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the trial. Following a screening polysomnogram participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg), or placebo nightly for 6 months (blinded groups A: n=15, B: n=11, C: n=13). After 6 months, nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned “blinded” medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos).

Results

Over the 14 nights 20 subjects took zero (51%) capsules; among the 19 taking capsules the median number chosen was 3. Most took one capsule per night; 6 took > 1 capsules on a given night. Importantly 1 subject took every capsule (42) available. Overall, the number of capsules taken declined from week 1 to 2 (p< .005). Those with baseline PSG SE <81% did not reduce capsule choice from week 1 to 2 (p<.02). Group A choose more capsules than groups B and C (p<.01).

Conclusion

The majority (85%) of the participants discontinued 6-month nightly hypnotic use (i.e. took < 6 total capsules over the 14 discontinuation nights) and among those taking capsules the rate declined from week 1 to 2. Baseline SE <81% may help identify those with difficulty discontinuing.

Support (If Any)

NIDA, grant#: R01DA038177 awarded to Dr. Roehrs.
0465 Exploring Differences in Self-Report Sleep Measures in Adults with Insomnia who Use or Do Not Use Sleep Medication
Authors: Tutek Joshua , Tully Isabelle , Simpson Norah , Manber Rachel
Published: May 2022

Introduction

Adults seeking non-pharmacological treatment for insomnia often present for care already taking prescription medication for sleep. Understanding how such patients differ from those who do not use medication could be useful for guiding treatment. This study examined associations between sleep medication use and measures of self-report sleep characteristics at baseline in an RCT of cognitive behavioral therapy for insomnia (CBTI).

Methods

We examined baseline data from 237 middle-to-older-aged adults with insomnia disorder (175 women, M age = 63.17) enrolled in the ongoing RCT on Effectiveness of Stepped-Care Sleep Therapy (RESTING). Participants were dichotomized by whether they reported taking at least one prescription medication for sleep. Sleep measures included the Insomnia Severity Index (ISI), PROMIS Sleep-Related Impairment short form, Epworth Sleepiness Scale (ESS), Cognitive Presleep Arousal Scale, Dysfunctional Attitudes and Beliefs About Sleep Scale, and two weeks of sleep diaries yielding average nightly sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality ratings. MANOVA compared medication users and non-users across sleep measures.

Results

Seventy-seven (32.5%) participants reported taking at least one prescription medication for sleep at baseline. MANOVA results indicated that sleep measures collectively differed by medication use, F(9, 226) = 3.74, p < .001; Wilk’s Λ = .87, partial η-sqd = .13. Bonferroni-adjusted follow-up comparisons (p < .005) found that only ESS significantly differed between medication users and non-users, F(1, 234) = 15.17, p < .001; partial η-sqd = .06. Medication users had lower sleepiness scores (M = 5.86, SD = 4.68) than non-users (M = 8.46, SD = 4.84). The association between medication use and less daytime sleepiness was maintained after adjusting for ISI.

Conclusion

Sleep medication use displayed little association with sleep measures in adults about to undergo CBTI, excepting endorsement of less daytime sleepiness by medication users. While more research is needed to understand the implications of sleep medication use for adults engaging in CBTI, these initial findings suggest that CBTI therapists should be thoughtful about sleepiness in non-medication users, and the potential emergence of sleepiness among patients who engage in sleep medication taper while in treatment.

Support (If Any)

1R01AG057500