throbber
VOLUME 38, 2015 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
`
`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
`
`SLEEP ~SSN: Ontne 1550-911)9; Website:
`WWN.joumalsleep.ag) is publshed on-lne
`monlhly pk.ls abs!ract in May by lhe Associat(cid:173)
`ed Professional Sleep Societies, LLC, a joint
`venl\l!'e of the American Academy of Sleep
`Medicine and the Sleep Research Society
`located at2510 North Frontage Road, Omen,
`IL60561-1511, phone (630)737-9700 and tax
`(630) 737-9790.
`
`Institutional Onlne (US and lntemationaQ:
`$425.00. Prorated subsaiptions 111e not
`avnilable. Subsaiptions begin with
`the
`January issue of the current year. Renew(cid:173)
`als should be secured as early in the ye111
`as possible to avoid uninterrupted service.
`Questions about subscriptions ~ncludlng
`payments, billing procedures. or polcy mat(cid:173)
`ters) should be directed to lhe APSS office at
`(630) 737-9700.
`
`ANNUAL SUBSCRIPTION RATES: Subo
`ADVERTISING: Q9tal adveltising is available
`saipllon rates tor Volume 38, 2015: lndivid-
`ual Online (US and lntemalklnal): $225.00; onjolmakleep.org. Please cantactthe Nation-
`
`al Sales Account Executiva at aclveltising@
`aasm1111tc:rg tor c:cmplete infcrmallon.
`
`associated wilh such permissions.
`
`REPRINTS: For author reprints contact lhe
`PERMISSION TO REPRODUCE: Witten APSS offlce. Fa commercial reprint aders
`permission to reptoduce, in print a electron!-
`contact Cenveo Publisher Services, 4810
`cally, whole a11icles a any parts of worlcs,lig- WiBiamsburg Road, #2, Hurlock, fi!D 21643
`ures « tables publshed in SLEEP must be
`or Reprints2@cadmus.com
`obtained pri« to publcation. Permission tor
`republcation must be arranged through the
`Cop)'right Clearance Cenll!f, Inc., 222 Rose(cid:173)
`wood Drive, Danvers, MA 01923, phone (978)
`75Q.8400 or fax (978) 646-8600 or URL http:l/
`ww.copyrightcom. There are royalty fees
`
`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
`
`

`

`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
`
`A222
`
`Page 3 of 3
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket