VOLUME 38, 2015 I ABSTRACT SUPPLEMENT
`
`JOURNAL OF SLEEP AND SLEEP DISORDERS RESEARCH
`ISSN 0161-8105
`
`291h Annual Meeting of the Associated
`Professional Sleep Societies, LLC
`
`Scientific Highlights/Abstracts of
`Original Investigations
`
`Click on the buttons below to jump to sections.
`
`Masthead
`
`Editorial
`
`Table of Contents
`
`Abstracts
`
`Author Index
`
`Keyword Index
`
`Page 1 of 3
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`EISAI EXHIBIT 1031
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`

`

`SLEEP
`
`JOURNAL OF SLEEP AND SLEEP DISORDERS RESEARCH
`
`Volume 38, 2015 1 Abstract Supplement
`
`Official publication of the Associated Professional Sleep Societies, LLC. A joint venture of the American Academy of Sleep Medicine and the Sleep Research Society.
`
`EDITOR IN CHIEF
`David F. Dinges, PhD
`
`Deputy Editors
`
`David S. Hui. MD. FccP
`Andrew D. Krystal. MD
`Samuel T. Kuna. MD
`Carol A. Landis. PhD. RN, FAAN
`Ralph Lydic. PhD
`Atul Malhotra. MD
`Rachel Manber. PhD
`Carole L. Marcus. MBChB
`Douglas McEvoy. MD
`Emmanuel Mignot MD. PhD
`Charles M. Morin. PhD
`
`Associate Editors
`
`Athanasios G. Kaditis. uo
`Vishesh Kapur. MD
`Max Kelz. MD. PhD
`Meir H. Kryger. MD
`Clete A. Kushida MD. PhD
`Kathryn A. Lee, PhD, RN
`Beth A. Malow. MD
`Jodi A. Mindel!. PhD
`Janet M. Mullington. PhD
`Matthew T. Naughton. MD, FRACP
`
`Book Review Editor
`Michael H. Bonnet PhD
`
`Editorial Board
`
`Kristen L. Knutson. PhD
`Hans-Peter Landolt PhD
`Peretz Lavie. PhD
`Peter Y. Liu, MSBS, PhD
`Steven W. Lockley, PhD
`Mark Mahowald. MD
`Bryce A. Mander. PhD
`George Mashour. MD, PhD
`W. Vaughn McCall. MD
`Dennis J. McGinty. PhD
`Thomas A. Mellman. MD
`Ralph Mistlberger. PhD
`Nicola Montano. MD. PhD
`Nirinjini Naidoo. PhD
`David N. Neubauer. MD
`Seiji Nishino. MD, PhD
`Bruce O'Hara. PhD
`
`Allan I. Pack. PhD. MBChB
`Sanjay R. Patel. MD
`Naresh M. Punjabi. MD. PhD
`Stuart F. Quan. MD
`Susan Redlin e. MD
`Dieter Riemann. PhD
`David B. Rye. MD. PhD
`Thomas E. Scammell. MD
`Jerome Siegel. PhD
`Michael H. Silber. MBChB
`
`Virend K. Somers. MD. PhD
`Ronald S. Szymusiak. PhD
`Fred Turek. PhD
`Hans P. Van Dongen. PhD
`Alexandros N. Vgontzas. MD
`Matthew P. Walker. PhD
`James K. Walsh. PhD
`Nathaniel F. Watson. MD
`Terry Young. PhD
`Phyllis C. lee. MD, PhD
`
`Louise M. O'Brien. PhD
`Maurice M. Ohayon. MD
`Mark R. Opp. PhD
`Sairam Parthasarathy. M>
`Paul E. Peppard. PhD
`Giora Pillar, MD. PhD
`Tarja Porkka-Heiskanen. PhD
`Larry D. Sanford. PhD
`Carlos H. Schenck. MD
`
`Richard J. Schwab. MD
`Patrick J. Strollo. MD. FCCP, FAASM
`Takeshi Tanigawa MD. PhD
`Eve V. Van Cauter. PhD
`Eus J.W. Van Someren.PhD
`Terri E. Weaver. PhD
`John R. Wheatley. MD. PhD
`John W. Winkelman. MD. PhD
`Juliane Winkelmann. MD
`Kenneth P. Wright Jr •• PhD
`
`Managing Editor
`Andrew Miller
`
`Lyle Olson. MD
`Jason C. Ong. PhD
`John Peever. PhD
`Philippe Peigneux. PhD
`Plamen Penev. MD. PhD
`Thomas Penzel. PhD
`Michael L Pertis. PhD
`Barbara A. Phillips, MD. MSPH, FCCP
`Dante Picchioni. PhD
`Gina R. Poe. PhD
`Thomas Pollmacher. MD
`Govinda R Poudel. PhD
`Gregg S. Pressman. MD. FAce
`Hengyi Rao. PhD
`David M. Rapoport. MD
`Renata L Riha, RPSGT. MD
`Timothy A. Roehrs. PhD
`Avi Sadeh. DSc
`
`Paula K. Schweitzer. PhD
`Kazue Sernba. PhD
`Paul J. Shaw, PhD
`Priyattam J. Shiromani. PhD
`Karine Spiegel. PhD
`Arthur J. Spielman. PhD
`Robert Stickgold. PhD
`Kingman P. Strohl. MD
`Deborah Suchecki. PhD
`Ariel T arasiuk. PhD
`Robert J. Thomas. MD
`Adrienne Tucker. PhD
`Sigrid C. Veasey. MD
`Arthur S. Walters. MD
`Nancy J. Wesensten. PhD
`Jonathan P. Wisor. PhD
`Amy R. Wolfson. PhD
`James K. Wyatt PhD
`
`Sonia Ancoli-lsrael. PhD
`Thomas J. Balkin. PhD
`Mathias Basner. MD. PhD, MSc
`Claude L Bassetti. MD
`Ruth M. Benca. MD, PhD
`Donald L Bliwise. PhD
`Jan Bom.PhD
`Daniel J. Buysse. MD
`Francesco Cappuccio. MBBs. MD. MSc
`Mary A. Carskadon. PhD
`
`Michael W. L Chee. MBBS
`Ronald D. CheNin. MD
`Chiara Cirem. MD. PhD
`Charles A. Czeisler. MD, PhD
`Christopher J. Earley. M>. PhD
`Colin A. Espie. PhD. FBPsS. Fcs
`Paul Franken. PhD
`Daniel J. Gottlieb. MD. tJPH
`David Gozal. MD
`David Hillman. MBBS
`
`Isabelle Amulf. MD. PhD
`Diane B. Boivin. MD, PhD
`Christian Cajochen. PhD
`Peter Cistulli. MD. PhD
`lan M. Colrain. PhD
`Michael Czisch. PhD
`Subimal Datta. PhD
`Christopher L Drake. PhD
`Raffaele F eni, MD
`James Gangwisch. PhD
`
`Charles F. George. MD
`Daniel G. Glaze. MD
`Namni Goel. PhD
`Nalaka S. Gooneratne. MD
`Robert W. Greene. MD. PhD
`Martica Hall. PhD
`Steven J. Henriksen. PhD
`Michael Irwin. MD, PhD
`Barbara E. Jones. PhD
`
`Executive Director
`Jerome A. Barrett
`
`Daniel Aeschbach. PhD
`Richard P. Allen. PhD
`Monica L Andersen. PhD
`J. Todd Amedt PhD
`Alon Y. Avidan. MD, wH
`M. Safwan Badr. MD
`Siobhan Banks. PhD
`David Barnes, MSBS, FCCP
`Celyne H. Bastien. PhD
`Dean W. Beebe. PhD
`Richard B. Berry. MD
`Edward 0. Bixler. PhD
`Bjorn BjoNatn. MD. PhD
`Orfeu Buxton. PhD
`Julie Carrier. PhD
`Peter Catcheside. PhD
`Thien Thanh Dang-Vu, MD. PhD
`Yves Dauvilliers. MD. PhD
`
`leslie C. Dort MSc. DDS
`Jeanne F. Duffy. PhD
`Marie Dumont PhD
`Charmane Eastman. PhD
`Jeffrey M. Ellenbogen. MD
`Julio Femandez-Mendoza PhD
`Peter C. Gay. MD
`Thomas J. Geller. MD
`Sina A. Gharib. MD
`Reut Gruber. PhD
`Christian Guilleminault MD
`Patrick Hanly, MD, D, ABDSM
`Rosemary S. Home. PhD
`Reto Huber. PhD
`Luca lmeri. MD
`Shahrokh Javaheri. MD
`Thomas S. Kilduff. PhD
`Elizabeth B. Klerman. MD. PhD
`
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`DISCLAIMER: The statements and opinims
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`journal ae solely those olthe au1hcrs thereof
`e> 2015 Associated Professional Sleep Soci(cid:173)
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`Sleep Medicine, the Sleep Research Society,
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`Page 2 of 3
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`

`

`B. Clinical Sleep Science
`
`Ill. Insomnia
`
`to examine the stability of sleep in a randomized controlled trial lilr
`chronic insomnia.
`~lcthods: Fifty-tour adults (74% female, mean age = 43 years) with
`chronic insomnia were randomized to I or 3 arms: I) 8-week Mind(cid:173)
`fulness-Based Stress Reduction (MBSR: n = 19). 2) 8-weck Mindful(cid:173)
`ness-Based Therapy tor Insomnia (MBTI: n = 19). or 3) 8-weeks of
`sett:.monitoring without treatment (SM: n = 16). Participants complet(cid:173)
`ed daily sleep diaries at baseline (7 days). during treatment/monitoring
`(63 days). and at post-week (7 days). The LSMM was conducted on
`sleep efficiency derived ti·om sleep diaries with three time (within(cid:173)
`subject) variables compared to baseline: early treatment (days I to 14),
`late treatment (days 15-63). and post-week. The two treatment arms
`(MBSR, MBTI) were compared to SM as between-subject variables.
`Results: The LSMM revealed that after adjusting tor mean levels, pa(cid:173)
`tients receiving MBSR had significantly less variance (i.e .. more stabil(cid:173)
`ity) in sleep efficiency compared to SM during early treatment (SD
`ratio= 0.70. p < 0.01) and late treatment (SO ratio= 0.70, p < 0.01), but
`not at post-week (SO ratio= 0.83, p = 0.20). MBTI was not significantly
`different from SM at early treatment (SD ratio= 0.96. p = 0.72). ap(cid:173)
`proached significance at late treatment (SO ratio= 0.81. p = 0.067). and
`was not significant at post-week (SO ratio= 0.84, p = 0.23).
`Conclusion: LSMM appears to be a viable statistical model for exam(cid:173)
`ining within-subject and between-subject variance of sleep parameters
`in randomized controlled trials. These findings indicate that insomnia
`patients report more stable sleep etliciency during MBSR treatment
`compared to SM without treatment.
`Support (If Any): National Institutes of Health. Grant number:
`K23AT003678
`
`0632
`EXPLORING OUTCOMES OF A SINGLE SESSION GROllP
`COGNITIVE BEHAVIORAL THERAPY FOR INSOMNIA
`INTERVENTION LED BY REGISTERED NURSES IN AN
`ACCREDITED SLEEP CENTER
`Moore WR 1• Sikkink VK 1, Heim-Penokie PC 1• Trapp GC.
`
`
`
`, lvnik AP. Auger RR 1
`Dierkhising RA 1, Burr L£1. Karls CL 1
`•
`Olson EP
`'Center tor Sleep Medicine, Mayo Clinic College of Medicine,
`Rochester, MN, 2Biomedical Statistics and Informatics. Mayo Clinic
`College of Medicine, Rochester, MN, 'Section of Patient Education,
`Mayo Clinic College of Medicine, Rochester, MN
`
`Introduction: This study explores the impact of a single session,
`group-based CBT-I program provided by registered nurses in an ac(cid:173)
`credited tertiary sleep center.
`Methods: Prospective study of patients with insomnia (N = 60. 29 re(cid:173)
`turned follow up measures). Sleep diaries. Pittsburg Insomnia Rating
`Scale (PIRS), and Dysfunctional Belief's about Sleep (DBAS) ques(cid:173)
`tionnaires were completed at baseline and 2 months after group CBT-1
`participation. Surveys reflecting patient satisfaction and selt:efficacy
`outcomes were obtained. Pre and post program outcome scores were
`compared. Associations of intervention use (;::: 3 vs < 3 times/week)
`with outcome differences (pre vs post) were assessed.
`Results: Statistically significant (p ~ 0.05) improvements in outcomes
`were: wake after sleep onset (median decrease 0.6 hours/day): sleep ef(cid:173)
`ficiency (median increase 6.5%): total sleep time (median increase 0.4
`hours.): PIRS (median decrease 8): DBAS (median decrease 0.9): and
`subjective responses to questions regarding quality of sleep. Neither
`sleep latency nor total time in bed changed significantly. The signifi(cid:173)
`cant associations (p ~ 0.05) of intervention use(;::: 3 vs < 3 times/week)
`with outcome ditlerences (pre vs post) were: restoration/refreshment
`by sleep with rela'\ation technique use (median decrease 0 vs 0.4); total
`sleep time with worry time use (median increase 0.9 hours vs median
`
`decrease 0.6 hours): subjective sleep quality with sett:.talk use (median
`decrease 0.1 vs median increase 0.4): sleep latency (median decrease
`10.7 minutes vs median increase 11.8 minutes): time in bed (median
`decrease 0.3 hours vs median increase 1.2 hours). and DBAS scores
`(median decrease 1.3 vs median decrease 0.7). with stimulus control
`use. 90% telt satisfied or very satisfied with the program. 67-73% indi(cid:173)
`cated the program at least moderately impacted attitude, behavior. and
`ability to manage insomnia.
`Conclusion: Participants reported improvements in sleep and high sat(cid:173)
`isfaction with the program, noting positive impact on selt:.management
`of insomnia.
`Support (If Any): Division of Pulmonary/Critical Care. Mayo Clinic
`
`0633
`PHARMACOKINETICS OF THE DlJAL OREXIN
`RECEPTOR ANTAGONIST E2006: RELATIONSHIP TO
`EFFICACY AND SAFETY
`
`
`Pastino G'. Murphy PJ 1• Bradshaw K1
`• Hall N1• Gupta A1
`Moline 1"fl. Beukmann C3• Ueno P. Ferry J 1
`'Eisai Inc., WoodcliiTLake, NJ, 2Eisai Ltd., Hatfield, United Kingdom.
`'Eisai Co. Ltd .. Tsukuba, Japan
`
`, A/uri J 1
`•
`
`Introduction: E2006 is a novel dual orexin receptor antagonist under
`development tor the treatment of insomnia disorder. This report pres(cid:173)
`ents results from an analysis assessing the impact of the PK profile on
`measures of efficacy and safety.
`Methods: Two Phase 1 randomized. double-blind. placebo-controlled
`studies determined the PK, PD and safety profile of E2006. E2006-
`AOOI-OOJ evaluated a single oral dose (1-200 mg) in healthy adult
`subjects (am dosing) and at 2.5. 10. and 25 mg in otherwise healthy
`subjects with primary insomnia (pm dosing). Multiple dose study
`E2006-AOOI-002 included healthy adult and elderly subjects (2.5-75
`mg). E2006-G000-201 was a US-based Phase 2, randomized, Bayes(cid:173)
`ian adaptive. double-blind. placebo-controlled. parallel group study
`of E2006 efficacy and safety in subjects with insomnia disorder ( 1-25
`mg). A population PK/PD model was constructed pooling data from
`these studies. Study 201 included objective and self-report measures of
`morning residual sleepiness.
`Results: E2006 exhibited linear PK following single dose adminis(cid:173)
`tration. Plasma concentrations were measurable 15 min after dosing,
`peaked by 2 hand decreased to< 13% ofCma'< by 9 h postdose at~ 10
`mg. The terminal tl/2 following multiple dosing was -50 h. but accu(cid:173)
`mulation was -2-told and consistent with a much shorter effective halt:.
`life ( 17-24 h). Efficacy by polysomnography and subjective reports was
`demonstrated by significant by decreases in sleep onset latency and
`wake after sleep onset. and increases in sleep efliciency. The popula(cid:173)
`tion exposure-response analysis demonstrated no impact on measures
`of morning residual sleepiness including the Digit Symbol Substitution
`Test. Simple or Choice Reaction Time tests. A higher incidence of som(cid:173)
`nolence and higher positive change on the Karolinska Sleepiness Scale
`were predicted at C9h > 20 ng/mL, but plasma concentrations in most
`ofthe population tell below this level at doses~ 10 mg.
`Conclusion: These results demonstrated that the PK of E2006 is com(cid:173)
`patible with a drug tor insomnia that improves both sleep onset and
`maintenance without clinically meaningful next-morning residual
`sleepiness.
`Support (If Any): These studies and analyses were supported by Eisai
`Inc.
`
`A221
`
`SLEEP. Volume 38, Abstract Supplement, 2015
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`Page 3 of 3
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