bluuebunny/crossref_metadata_2025_split huggingface dataset:
0333 INSOMNIA WITH OBJECTIVE SHORT SLEEP DURATION IS ASSOCIATED WITH INCIDENT CARDIOVASCULAR AND/OR CEREBROVASCULAR DISEASE
Authors: Karagkouni Efthalia , Fernandez-Mendoza Julio , He Fan , Bixler Edward , Karataraki Maria , Vgontzas Alexandros 
Published: May 2023

Abstract

Introduction
Insomnia with objective short sleep duration (ISSD) has been associated with adverse cardiometabolic outcomes, including hypertension and diabetes. However, data on the association between ISSD and the development of cardiovascular and/or cerebrovascular disease (CBVD) are limited. We aimed to examine whether ISSD is associated with incident CBVD.

Methods
1,211 men and women from the Penn State Adult Cohort (56.9% women, 51.82±12.85 years) without CBVD at baseline were followed up for 9.21±4.08 years. Based upon clinical history and physical examination, we defined the presence of CBVD as a history of diagnosis or treatment of heart disease and/or stroke. Insomnia was defined as a complaint of insomnia with a duration ≥ 1 year. Poor sleep was defined as a complaint of difficulty falling asleep, staying asleep, nonrestorative sleep or early morning awakening. Objective short sleep duration was defined as &lt; 6-hours sleep based on a 1-night, 8-hours, in-lab polysomnography. Logistic regression models examined the odds of incident CBVD, while simultaneously adjusting for race, sex, age, BMI, smoking, alcohol use, physical and mental health problems, sleep-disordered breathing and follow-up duration.

Results
Compared to normal sleepers with normal sleep duration, the highest risk of incident CBVD was in the ISSD group (OR=2.68, 95%CI=1.17-6.14), and the second highest in normal sleepers with short sleep duration (OR=1.65, 95%CI=1.10-2.49). The risk for incident CBVD was not significantly increased, in poor sleepers or those with insomnia with normal sleep duration (INSD).

Conclusion
Our findings indicate that the combination of short sleep duration with the complaint of chronic insomnia (ISSD) is associated with an additive effect on incident heart disease and stroke. These data add to the cumulative evidence supporting the existence of two insomnia phenotypes and that ISSD is the more severe biological phenotype of the disorder associated with physiologic hyperarousal and cardiovascular morbidity. The diagnostic and treatment implications of insomnia phenotyping based on objective sleep duration will be discussed.

Support (if any)
0334 INSOMNIA WITH OBJECTIVE SHORT SLEEP DURATION IS ASSOCIATED WITH METABOLIC SYNDROME
Authors: Karagkouni Efthalia , Fernandez-Mendoza Julio , He Fan , Bixler Edward , Karataraki Maria , Vgontzas Alexandros 
Published: May 2023

Abstract

Introduction
Several studies have shown that the insomnia with objective short sleep duration (ISSD) phenotype is associated with stage 2 hypertension and type 2 diabetes. We aimed to determine if there is an association between ISSD and metabolic syndrome (MetS).

Methods
We studied 1,741 adults from the Penn State Adult Cohort (age 20-88 years, 52.3% female, 12.4% racial/ethnic minority) who underwent a 1-night polysomnographic (PSG) evaluation, clinical history, and physical examination. Insomnia was defined as a complaint of insomnia with a duration ≥ 1 year, while poor sleep was defined as a complaint of difficulty falling asleep, staying asleep, nonrestorative sleep or early morning awakening. Objective short sleep duration was defined as &lt; 6-hours. MetS was defined by the presence of 3 or more of: BMI≥30 kg/m2, elevated total cholesterol (≥200 mg/dL), triglycerides (≥150 mg/dL), fasting glucose (≥100 mg/dL), or treatment, and blood pressure (≥130/85 mm Hg) or treatment. Logistic regression models examined the odds of developing MetS, while simultaneously adjusting for sex, race, age, alcohol, smoking, sleep-disordered breathing, mental and physical problems, and sampling weight.

Results
Compared to normal sleepers with normal sleep duration, ISSD was associated with a significantly increased risk of MetS (OR=2.04, 95%CI=1.13-3.70), while insomnia with normal sleep duration (INSD) was not (OR=1.03, 95%CI=0.53-1.99). Neither normal sleepers with short sleep duration nor poor sleeper with normal or short sleep duration were associated with increased risk of MetS. Further analysis of the clustering of the cardiometabolic risk factors revealed that in the ISSD group who had MetS, 94% had elevated blood pressure, 78% had elevated cholesterol, 72% had insulin resistance, 53% had elevated triglycerides, and 53% had BMI≥30 kg/m2.

Conclusion
These data indicate that hypercholesterolemia, but not hypertriglyceridemia or obesity, contributes to the association of ISSD with MetS. These data suggest that in addition to the previously-identified elevated blood pressure and insulin resistance, treatment of hypercholesterolemia in patients with ISSD may prevent the development of cardiovascular and cerebrovascular disease.

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0336 Tele-Self CBTi: Results of a Randomized Controlled Trial of a Nurse-Supported Self-Management Intervention for Insomnia Disorder
Authors: Ulmer Christi , Voils Corrine , Zervakis Jennifer , Goodwin Kaitlyn , Jeffreys Amy , Gentry Pamela , Rose Cynthia , Olsen Maren , Bosworth Hayden B 
Published: May 2023

Abstract

Introduction
Approximately half of all Veterans meet diagnostic criteria for Insomnia Disorder. Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended as first-line treatment but access is limited. Self-help CBTi could increase patient access and is more effective with provider support. Self-help CBTi has not been evaluated in those with significant mental health morbidity or Veterans; a population having greater medical and mental health morbidity and more severe sleep difficulties than non-Veterans.

Methods
Treatment-seeking Veterans were randomly assigned to 6 sessions of Tele-Self CBTi or Health Education Control (HEC). Nurses without sleep medicine experience were trained to deliver Tele-Self CBTi; the combination of provider support plus professionally designed patient and provider CBTi treatment manuals developed through an iterative process integrating expert and patient feedback. Both arms received nurse phone contacts (≤20 minutes). Outcomes including insomnia severity, subjective and objective sleep parameters, fatigue and mood were assessed at baseline, post-treatment (8 weeks), and 6 months.

Results
Study participants (N=178) were 55 years of age (SD=13), mostly male (72%), with a mental health condition (83%), and about half African American (43%) and half Caucasian (49%). At post-treatment, Veterans randomized to Tele-Self CBTi realized greater reductions in insomnia severity (ISI estimated mean improvement 5.7 vs 2.0, p&lt;.001) and greater improvements in fatigue and depression symptoms (ps&lt;.04). At 6 months, ISI findings were sustained (5.3 vs. 2.4, p&lt;.001) and more Tele-Self CBTi than HEC participants (32% vs 10%) scored below the cutoff suggestive of insomnia disorder (ISI&lt; 11) (p=.001). Preliminary findings also suggest better post-treatment outcomes for Tele-Self CBTi on sleep diary SOL (25 vs 45 minutes) and WASO (34 vs 55 minutes).

Conclusion
A self-management CBTi requiring minimal provider resources was effective in reducing insomnia severity in veterans with considerable mental health co-morbidity. Tele-Self CBTi can help bridge the gap between unavailable resources and high demand for services and can serve as the entry level in stepped-care treatment for insomnia disorder. Future research is needed to identify characteristics of patients most likely to benefit from Tele-Self CBTi.

Support (if any)
Funding was provided by Veterans Affairs Office of Research and Development (CIN 13-410 and IIR 16-281).
0338 A Naturalistic within and between Subjects Comparison of the effects of Cannabis on Sleep among Young Adult, African Americans
Authors: Hurst Travan , Lavela Pewu , Sandhu Ishaan , Mellman Thomas 
Published: May 2023

Abstract

Introduction
Cannabis use is increasing, despite limited knowledge of its potential benefits and adverse effects. Reducing sleep disturbance appears to be a frequent motivation for nighttime cannabis use yet its effects on sleep are poorly documented. We leveraged data from an observational study of urban residing young adult African Americans where pre-bedtime cannabis use was variably endorsed with digital ecological momentary assessment (EMA) to conduct within and between subjects’ comparisons of sleep with and without preceding cannabis use.

Methods
Participant were recruited from an ongoing observational study that enrolls African Americans living in urban environments. 20 participants endorsed cannabis use on some but not all nights and were included in the within subjects’ comparison. 25 participants who used cannabis on 2 or more nights were compared with 28 participants who did not endorse prebedtime substance use. Total sleep time (TST), and wake after sleep onset WASO were derived from actigraphy monitoring; sleep quality (SQ) (scale: 1 “not at all rested”-10 “very rested”) and time in bed (TIB) were obtained from the EMA.

Results
While TST and WASO were very similar in both conditions and groups, within subjects’ SQ was superior on nights without cannabis (7.2 + 1.7 vs. 6.4 + 2.2, t=2.2, p=.04) and cannabis users spent more time in bed (minutes) than their non-cannabis using counterparts (447.6 + 77.1 vs. 373.6 + 66.1; t= 2.4, p=.04).

Conclusion
Among urban residing young African American adults, cannabis does not appear to improve sleep.

Support (if any)
This research was supported by the NIHLB grant R01HL136626 to Dr. Thomas A. Mellman.
0339 A phenomenological study on facilitators and barriers of Zero-time exercise in physically inactive adults with insomnia disorder
Authors: Chau Ching Sum , Yeung Wing Fai , Chen Shu Cheng , Lai Yuen Kwan , Lam Tai Hing 
Published: May 2023

Abstract

Introduction
Zero-time Exercise (ZTEx), a lifestyle-integrated exercise, might have beneficial effects on relieving insomnia. Exercise adherence is a key component for the success of exercise therapy. This study is to explore facilitators and barriers of Zero-time exercise adherence and the improvement in sleep quality in physically inactive adults with insomnia disorder.

Methods
The qualitative study used ten 1-hour focus group interviews (5 groups at immediately after training program, and groups at the end of 24-week study period) on improving sleep quality of 35 physically inactive adults with insomnia disorder who had enrolled in our previous randomized controlled trial, from Oct 2019 to Mar 2022. A framework approach with a semi-structured interview guide was used to reflect subjects' facilitators and barriers of adherence to Zero-time exercise. Different strategies were used to ensure the credibility, dependability, confirmability, and transferability of the study. Transcripts were analyzed using qualitative thematic content analysis. The interviews were audio-recorded and transcribed verbatim. In addition, the contents of each group were summarized into generalized descriptions using NVivo 11.0.

Results
35 physically inactive adults with insomnia disorder (female: 58.7%, mean age: 47.2 years). Four themes were identified: (1) perceived benefits or changes (e.g. perceived better sleep quality; perceived improved physical health and more energetic, and positive lifestyle changing), (2) facilitators to intervention delivery (e.g. the understanding of benefits of doing exercises and risks of not doing exercise, expectations of participants, monitoring and reminders provided in the study, and belief and responsibility of participation), (3) barriers to intervention delivery (e.g. difficulties in integrating exercises into daily live, physical health challenges faced by participants, limited improvement, and lack of support from people around) and (4) suggestions from participants (e.g. modifying the content of ZTEx to be more interesting; and providing more easily accessible exercise video).

Conclusion
Participants perceived benefits from the ZTEx intervention besides improving sleep quality. Participants’ compliance could be further enhanced if more assistance in helping them to integrate exercise into daily life. Social and familial support was also essential for their adherence.

Support (if any)
The study was supported by the Research Grants Council, General Research Fund, Hong Kong SAR (Project no.: 15100419)
0341 Acupuncture and Its Effects on Various Patterns of Insomnia
Authors: Tipaldo Kristen , Seixas Azizi , Chery Maurice , Bernard Maritza , Jean-Louis Girardin , Blanc Judite 
Published: May 2023

Abstract

Introduction
Acupuncture has been shown to treat Insomnia. Insomnia is classified as difficulty falling asleep and staying asleep, waking up throughout the night, and waking up early, which is associated with decreased daytime function, mental health, and cardiometabolic health. The purpose of our study is to describe a series of 12 cases seen in an Acupuncture Clinic in Tampa for symptoms of Insomnia.

Methods
We used intakes from eight females, seven Caucasians, one African American, and four Caucasian males aged 30-65 and assessed information through Acupuncture systems. Patients were seen for Insomnia along with other treatable symptoms between January 2019 and October 2022. Information on Gynecological, Orthopedic, Genito-Urinary, Psycho-Emotional, Gastrointestinal, Respiratory, Ear/Nose/Throat, Neurological, Endocrine, and Allergic/Immunologic were collected. Follow-up intake information and Subjective, Objective, Assessment Plan (SOAP) notes were conducted during each visit through the electronic medical system. Differential diagnosis, as well as ICD codes, are housed within the system. The Acupuncture method utilized was Traditional Chinese Medicine (TCM) and not dry needling, which does not include a differential diagnosis and is typically used for Orthopedic conditions.

Results
We retrieved data from twelve patients, eight women and four men receiving Acupuncture treatment in private practice. The mean age of the sample was 46.91 [30-65] years. Of the 12 patients, 10 of them fully recovered after treatment. Among those who fully recovered, treatments ranged as low as two up to 14, with three patients receiving six treatments and one receiving 14. One patient discontinued treatment after six treatments with a slight change to differential insomnia pattern. One patient received fourteen treatments with only partial remission to differential insomnia pattern.

Conclusion
Acupuncture may be an effective modality in treating Insomnia, regardless of the pattern. Further studies are necessary to determine the mechanism of action.

Support (if any)
R01HL152453, R01MD007716, and R01HL142066
0342 Are Clinical Trials for Insomnia Recruiting Real World Patients?
Authors: Golebiowski Raphael , Kolla Bhanuprakash , Mansukhani Meghna 
Published: May 2023

Abstract

Introduction
Studies that have resulted in recent approval of hypnotics for chronic insomnia disorder (CID) have extremely restrictive inclusion criteria. We sought to determine how many patients seen in a sleep medicine clinic would be eligible to participate in these trials in order to assess the generalizability of these findings to clinical populations.

Methods
Six-hundred and twenty-eight patients were screened to identify 100 patients who were ≥18 years old, had a diagnosis of CID, and were prescribed a hypnotic medication at a sleep medicine clinic in a quaternary level healthcare center. Information regarding age, sex, body mass index, comorbid diagnoses, sleep schedule, medications, alcohol/tobacco/illicit drug use, caffeine intake, as well as Epworth Sleepiness Scale, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, and Insomnia Severity Index scores were abstracted. These data were compared against the inclusion and exclusion criteria for recent regulatory Phase III trials of orexin receptor antagonists (suvorexant, lemborexant, daridorexant).

Results
Of the 100 patients with CID (mean age=56.2 years; 57% female), only 3 patients met eligibility criteria for inclusion. A majority of patients (80%) would have been excluded due to a prior/concurrent trial of cognitive behavioral therapy for insomnia. If this criterion was set aside, only 11 patients would have been eligible to participate. The remaining top reasons for potential exclusion from the regulatory trials were: presence of medical comorbidities (36%), daytime napping (33%), and sleep apnea (30%).

Conclusion
A very small number of patients with CID seen in a clinical setting met eligibility criteria for clinical trials of hypnotic medications resulting in regulatory approval. This substantially limits the generalizability of findings from these trials and restricts our ability to determine the efficacy of these drugs in clinical populations. Future trials should enroll patients with less restrictive criteria to help determine the effectiveness of these medications in real world settings.

Support (if any)
0343 Association between the real-world use of trazodone and daytime impairment in US patients with insomnia
Authors: Büsser Alexander , Olivieri Antonio , Grandner Michael , McCall William V 
Published: May 2023

Abstract

Introduction
Trazodone is approved for the treatment of depression and is used off-label to treat insomnia despite Clinical Practice Guidelines recommending against this use. The objective of this real-world retrospective study is to explore whether trazodone use is associated with improvements in daytime impairment in US patients with insomnia.

Methods
Information on insomnia patients aged ≥ 18 years prescribed trazodone as first-line treatment between October 2015 and March 2020 was retrieved from HealthVerity. Insurance claims data were extracted for each patient alongside physician notes in free-text form. From the claims, patient demographics and prescription information were extracted. An ontology analogous to the Insomnia Daytime Symptoms and Impact Questionnaire (IDSIQ) was designed with three domains (i.e., alert/cognition, mood and sleepiness). The 14 IDSIQ terms were extended to 109 terms to reflect physicians’ language. Daytime impairment symptom frequency occurring from 182 days before treatment to ~3 months (mean) during treatment was measured as annualized rates normalized by one year as the duration before and during treatment is different. Each symptom noted in a visit is counted once in a specific domain. Results were stratified by dose: trazodone &lt; 150mg (typically used for off-label insomnia treatment) and trazodone ≥150mg (approved dose for depression treatment).

Results
1187 and 246 unique patients were identified on the &lt; 150mg and ≥150 mg trazadone doses, respectively. For trazodone &lt; 150mg, the annualized rate of daytime impairment symptoms before and during treatment was 139.4 and 147.5, respectively, with a statistically non-significant overall increase (6%, p=0.313) and statistically non-significant increases in each domain (alert/cognition: 4%,p=0.574; mood: 10%, p=0.173; sleepiness: 5%,p=0.401). For ≥150mg trazodone, the annualized rate of daytime impairment symptoms before and during treatment was 143.5 and 142.2, respectively, with a statistically non-significant overall decrease (1%,p=0.941), statistically non-significant decreases in the alert/cognition (19%,p=0.128) and sleepiness (5%,p=0.712) domains and statistically non-significant increase in the mood domain (14%,p=0.400).

Conclusion
Patients with insomnia prescribed trazodone show similar levels of daytime impairment before and during treatment. This study suggests that the use of trazodone in patients with insomnia is not associated with a decrease in daytime impairment.

Support (if any)
Idorsia Pharmaceuticals Ltd.
0344 Behavioral Treatment of Insomnia with Concurrent Nocturia
Authors: Tyagi Shachi , Clarkson Becky , Perera Subashan , Newell Kandy , Resnick Neil , Buysse Daniel 
Published: May 2023

Abstract

Introduction
Behavioral therapy has proved effective for insomnia in older adults. However, its efficacy has not been examined among those with nocturia (awakening to urinate) which is the most common cause of insomnia in this age group. Thus we assessed the impact of behavioral sleep treatment on sleep in older adults with nocturia.

Methods
Fifty-six community-dwelling older adults (mean age, 72±6 years; 64% women) with nocturia frequency ≥2 per night were randomized to receive Brief Behavioral Treatment for Insomnia (BBTI) or information-only control (IC). We determined the impact of BBTI on sleep, sleep quality, and nocturia as assessed by a 3-day voiding and sleep diary. Participants concurrently wore a single-channel, EEG device Z-machine® for objective in-home sleep assessment. Insomnia Severity Index (ISI) was used to assess insomnia symptoms.

Results
Participants had a mean nocturia frequency of 2.2±0.7/night at baseline. Time in bed (TIB) decreased by 42±76 minutes among the BBTI group, but total sleep time (TST) increased by 20±95. Significant differences ± standard error between BBTI and IC in pre- to post-intervention changes were observed for TIB (-41±18 minutes, p=.03) but not TST (27±18, p=.14). Compared to the IC group, the BBTI group also showed a greater improvement in ISI (-3.3±1.4, p=.02) as well as objectively measured sleep onset latency (-9.8±3.5, p=.008), latency to deep sleep (-19±11, p=.08), and percentage of total sleep time spent in deep sleep (8.4±3.1, p=.01). BBTI also decreased nocturia frequency to a greater extent (-0.49±0.20, p=.02)

Conclusion
BBTI improves insomnia symptoms, objective sleep measures, and nocturia in older adults with frequent sleep interruptions related to nocturia. Treatment for insomnia may be an important addition to current treatments for nocturia.

Support (if any)
NIA AG 060292
0345 BZRA Hypnotic Receptor Specificity and Ability to Discontinue Chronic Hypnotic Use
Authors: Roehrs Timothy , Koshorek Gail , Roth Thomas 
Published: May 2023

Abstract

Introduction
Clinicians prescribing hypnotics remain concerned regarding the inability to discontinue hypnotics after chronic use. In a controlled prospective study using self-administration choice procedures we tested whether BZRA hypnotic receptor specificity is predictive of discontinuation difficulty in a clinical trial in which insomnia subjects are instructed to stop taking their study medication after 6 months of nightly use.

Methods
DSM-V diagnosed insomnia subjects, aged 23-61 yrs, (n=41, 36 females), with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the trial. Following a screening polysomnogram and MSLT, participants were randomized to zolpidem XR 12.5 mg (n=16), eszopiclone 3 mg (n=11), or placebo (n=14) nightly for 6 months. 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 21 subjects took zero (51%) capsules; among the 20 taking capsules the median total number chosen over the two weeks was 3. Most took one capsule per night; 6 took &gt; 1 capsule on a given night. Overall, the number of capsules taken declined from week 1 to 2 (p&lt; .001). The eszopiclone group took a greater number of capsules than the placebo group (p&lt;.005), with the zolpidem group between. The eszopiclone group also showed a trend (p&lt;.07) to fail to reduce use from week 1 to 2.

Conclusion
The majority (51%) of the participants discontinued 6-month nightly hypnotic use and among those taking capsules the rate declined from week 1 to 2. The non-hypnotic receptor specific eszopiclone group took a greater number of capsules than the placebo group. This is the first ­demonstration of differential abuse liability among BzRA hypnotics.

Support (if any)
NIDA, grant#: R01DA038177 awarded to Dr. Roehrs.