`
`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.
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`Masthead
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`Editorial
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`Table of Contents
`
`Abstracts
`
`Author Index
`
`Keyword Index
`
`Page 1 of 3
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`EISAI EXHIBIT 1030
`
`
`
`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
`Charfes M. Morin. PhD
`
`Associate Editors
`
`Athanasios G. Kaditis. MD
`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. Mindell. 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. Uu. MBBS, 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 Mistiberger. 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 Redline. 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. Zee. MO. PhD
`
`louise M. O'Brien. PhD
`Maurice M. Ohayon. MD
`Mark R. Opp, PhD
`Sairam Parthasarathy. MD
`Paul E. Peppard. PhD
`Giora Pillar. MD. PhD
`Taqa 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
`AndrewMmer
`
`lyle Olson. MD
`Jason C. Ong, PhD
`John Peever. PhD
`Philippe Peigneux. PhD
`Plamen Penev. MD. PhD
`Thomas Penzel. PhD
`Michael L Perfis. 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. oSc
`
`Paula K. Schweitzer. PhD
`Kazue Semba. 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 Tarasiuk. 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. WBS
`Ronald D. Chervin. MD
`Chiara Cirelli. 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. MPH
`David Gozal. MD
`David Hillman. MBBS
`
`lsabeDe 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 Ferri. MD
`James Gangwisch. PhD
`
`Charfes 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. PnD
`
`Executive Director
`Jerome A. Barrett
`
`Daniel Aeschbach. PhD
`Richard P. Allen. PhD
`Monica L Andersen. PhD
`J. Todd Amedt PhD
`Alan Y. Avidan. MD. MPH
`M. Safwan Badr. MD
`Siobhan Banks. PhD
`David Barnes. MBBS, FCCP
`Celyne H. Bastien. PhD
`Dean W. Beebe. PhD
`Richard B. Berry. MD
`Edward 0. Bixler. PhD
`Bjorn Bjorvatn. MD. PhD
`Orfeu Buxton. PhD
`Julie Carrier. PhD
`Peter Catcheside. PhD
`Thien Thanh Dang-Vu. MD. PhD
`Yves DauviUiers. MO. PhD
`
`leslie C. Dort. MSc. DDS
`Jeanne F. Duffy. PhD
`Marie Dumont PhD
`Charmane Eastman. PhD
`Jeffrey M. Ellenbogen. MD
`Julio Fernandez-Mendoza. PhD
`Peter C. Gay. MC
`Thomas J. Geller. MD
`Sin a 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 opinions
`contained in editorials and l!l1icles in lhls
`journal are solely those of the aulhors thereof
`and not of the Associated Professional Sleep ~ 2015 Associated Professional Sleep Sod(cid:173)
`Societies. LLC, the American Academy of eties. LLC.
`
`Sleep Medicine, the Sleep Research Society,
`a of their officers, regents, members a em(cid:173)
`ployees. The Edit«-l!K:hief, the Associated
`Professional Sleep Societies. the American
`Academy of Sleep Medicine, the Sleep Re(cid:173)
`search Society, and officers. regents, mem(cid:173)
`bers and employees disclaim all responsibitty
`tor any injury to persons « property resulling
`tram any ideas a products referred to in ar(cid:173)
`lides contained in this j01.mal.
`
`Page 2 of 3
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`
`
`B. Clinical Sleep Science
`
`lll.lnsomnia
`
`0634
`TRAINED SLEEP PHYSICIANS CA~ EFFECTIVELY
`ADMI~ISTER COGJ\ITIVE BEHAVIORAL THERAPY
`FOR I~S0:\1:"\IA (CBTI) I~ THE CLI~ICAL SETTI~G
`Peters BR'"
`1Stantord University Department of Psychiatry and Behavioral
`Sciences. Redwood City. CA. !Pulmonary and Sh:cp Associates of
`Marin. Novato. CA
`
`Introduction: Psychologists typically conduct cognitive behavioral
`therapy lor insomnia (CBTT). Few sleep physicians arc formally
`trained and actively practice CBTI. The effectiveness and merits of
`CBTI as administered by a sleep physician in a community-based
`clinic is unknown.
`.\'lethods: A retrospective chart review was performed of 110 patients
`presenting with chronic insomnia from October 2013 to October 2014
`who enrolled in CBTI with a tbrmally trained sleep physician at a com(cid:173)
`munity-based clinic. The modified program consisted of 4 to 6 ses(cid:173)
`sions lasting 30 to 60 minutes and emphasized sleep education. sleep
`consolidation. and relaxation training. Subjects were excluded if they
`did not attend at least 4 sessions. inadequately completed sleep logs. or
`if untreated sleep apnea interfered with compliance. The outcomes as(cid:173)
`sessed included changes in sleep-onset latency, wakefulness after sleep
`onset, total sleep time. and sleep efflciency from baseline to conclusion
`ofthc program.
`Results: Of the 110 su~jects enrolled, 21 su~jects were excluded (13
`didn't auend at least 4 sessions. 4 inadequately completed sleep logs.
`and 4 had untreated known sleep apnea reducing compliance). There(cid:173)
`maining 89 su~jects were 65% women and 35% men. The a\'erage age
`was 60.69 years (ranging from 12 to 90 years). Sleeping pills were used
`at baseline in 74.2% (66 subjects) and obstructive sleep apnea (AHI > 5
`on testing) was identified in 65.2% (58 subjects). Improvements were
`seen in all averaged measures from baseline to program conclusion:
`sleep-onset latency (55.5 to 22.5 minutes), w·akefulness after sleep on(cid:173)
`set (45.17 to 25.21 minutes). total sleep time (6.22 to 6.25 hours), and
`sleep efficiency (74.0% to 85.5%).
`Conclusion: CBTI is highly etlective when administered by a trained
`sleep physician and can be successfully integrated into standard clini(cid:173)
`cal practice. Physicians may be beuer equipped to taper sleeping pills
`and to identify and treat comorbid sleep conditions.
`
`0635
`INSOMNIA IN PEOPLE LIVING WITH HIV/AIDS
`SliCCESSFlfLLY TREATED BY COG~ITIVE
`BEHAVIORAL TREATMENT
`• Means AP. Riordan P1
`Preud 'hom me XA 1
`• Besnainou S!. Fleenor J 1
`,
`Smith P1• Bridgers J 1• Krystal A D1
`1Duke University School of Medicine. Durham. NC. !University of
`Pennsylvania, Philadelphia PA
`
`Introduction: The triad insomnia-fatigue-depression aftects 50 to
`100% of people living with HIVIAIDS (PLWHA), with 1.2 million in
`the US. This study intends to establish the feasibility of allied-health
`personnel administered cognitive behavioral therapy for insomnia
`(CBTI) in PLWHA.
`Methods: 27 HIV-seropositive subjects, 11.2% Caucasians and 85.2%
`African-Americans. including 8 females (29.6%). aged 43-59 years.
`with insomnia for at least 3 months and all currently taking HAART
`were enrolled. Screening process included the Duke Structured Inter(cid:173)
`view for Sleep Disorders. to ascertain sleep disorder diagnoses. Last
`observation carried tbrward (LOCF) and T-test were utilized.
`Results: There was no statistical difference between the treatment
`group (n = 15) and the placebo group (n = 12) for age. height, weight.
`
`gender and race/ethnicity distribution. therapist allocation. Th~re was
`no statistically signifkant difference across both groups tor skcp(cid:173)
`diary derived sleep etlicicncy-SE (CBTI: 68.5~;;, ± 12.0: Placebo:
`62.7% ± 14.8: p = 0.29). and tor th~.: insomnia sev~.:rity index-lSI
`(CRTI: 16.9 ± ..J.6: Placebo: 16.3 ± 7.1: p = 0.8). Blinding was effec(cid:173)
`tive as perceived tr~atment by subjects was similar regardless of ac(cid:173)
`tual treatment allocation (Chi-squared = 0.675 with I dt: two-tailed
`p = 0.41). Treatment was efti:ctive with a final SE of 85.0% ± 11.2 t(lr
`the CBTI v~rsus 71.8% ± 15.0 tbr the placebo group (p = 0.02) yield(cid:173)
`ing a number needed to treat (NNT) of8 and a Cohen's d etlcct size of
`0.91: as well as a final lSI of 11.3 ± 6.9 tor the CBTI versus 16.6 ± 5.6
`f(lr the placebo group (p = 0.036) yielding a NNT of 19 and an etTect
`size of 0.78.
`Conclusion: While insomnia is at least twice more prevalent in
`PLWHA than in the general population. we demonstrated that it can be
`effectively treated with a non-pharmacological therapy (CBTI ). more(cid:173)
`over when administered by allied-health personnel and over 4 \Vcekly
`sessions.
`Support (If Any): The Duke University Center for AIDS Research
`(CFAR). an NIH funded program (5P30AI064518)
`
`0636
`DllAL OREXIN RECEPTOR ANTAGONIST E2006
`SHO\VS EFFICACY 0~ SLEEP 11\ITIATION A~D
`MAINTENA~CE ON SLEEP DIARY l\IEAStJRES IN
`PHASE 2 STl r DY
`Moline .\.JI, Murphy PJ'. Giorgi F. Bradshaw K~. Berkman U.
`Yardley F. Sat/in A 1
`'Eisai Inc .. Woodclitl'Lake. NJ. 2Eisai Ltd .. Hatfield. United Kingdom
`
`Introduction: Increasing attention has been paid to dual orexin recep(cid:173)
`tor antagonists (DORA) to treat insomnia. This report presents Phase 2
`sleep diary results with E2006. a novel DORA.
`Methods: The study was a multicenter (US). randomized. double(cid:173)
`blind. placebo-controlled. parallel group design. enrolling subjects
`with insomnia disorder per DSM-5. A Bayesian adaptive design tested
`6 strengths of E2006 (I. 2.5. 5. 10. 15. 25 mg) or placebo adm inis(cid:173)
`tered for 15 nights (30m before bedtime). Diaries were completed each
`morning. Safety was monitored via treatment-emergent adverse events
`(TEAEs}. ECGs, vital signs, chemistries and morning assessments of
`residual sleepiness (in-clinic only). Sleep efficiency (SE). subjective
`Sleep Onset Latency (sSOL) and subjective Wake After Sleep Onset
`(sWASO) from sleep diaries were averaged tor Baseline (BL} and dur(cid:173)
`ing treatment (Days 1-7. 8-15).
`Results: 616 screened. with 291 randomized (63.5% F. mean age 48 y).
`Mean (SO) BL Insomnia Severity Index was 20 ± 3 (moderate-severe).
`Demographics were similar between treatment groups. Overall mean
`(SO) BL values were SE: 65 ± II%: sSOL: 59± 33 m; sWASO: 110 ± 48
`m. 94.5% of E2006 and 91.1% of placebo subjects completed. Dur(cid:173)
`ing Days 1-7, the LS mean ditlerence (E2006 vs placebo) fbr change
`from BL in SE was statistically significant tor 5-25 mg, increasing
`6-9.4% with overlapping confidence intervals. Except with I mg. sSOL
`decreased significantly. with median change from BL from -23 min
`(2.5 mg) to -26 min (25 mg): placebo -10 min. sWASO decreased
`in all treatment groups (significantly for to mg: LS mean difterence:
`-29 min). Benefits seen tor Days 1-7 were maintained for Days 8-15.
`TEAEs were more common with E2006. Somnolence was dose-related.
`There were 2 SAEs (one placebo; one 25 mg [discontinued study]). All
`TEAEs except the SAE at 25 mg were mild or moderate.
`Conclusion: These data highlight the potential of E2006 to treat in(cid:173)
`somnia disorder. E2006 was well-tolerated in this study. with mild(cid:173)
`moderate adverse events. Subject-reported efficacy was demonstrated
`for both sleep onset and sleep maintenance.
`
`SLEEP, Volume 38, Abstract Supplement. 2015
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`A222
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`Page 3 of 3
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