PMID- 23871259
OWN - NLM
STAT- MEDLINE
DCOM- 20140512
LR  - 20220331
IS  - 1878-5506 (Electronic)
IS  - 1389-9457 (Print)
IS  - 1389-9457 (Linking)
VI  - 14
IP  - 9
DP  - 2013 Sep
TI  - A multicenter evaluation of oral pressure therapy for the treatment of 
      obstructive sleep apnea.
PG  - 830-7
LID - S1389-9457(13)00187-1 [pii]
LID - 10.1016/j.sleep.2013.05.009 [doi]
AB  - OBJECTIVE: We aimed to evaluate the impact of a novel noninvasive oral pressure 
      therapy (OPT) (Winx(R), ApniCure) system on polysomnographic measures of 
      sleep-disordered breathing, sleep architecture, and sleep stability in 
      obstructive sleep apnea (OSA). SUBJECTS AND METHODS: A 4-week, multicenter, 
      prospective, open-label, randomized, crossover, first-night order of control vs 
      treatment, single-arm trial was conducted in five American Academy of Sleep 
      Medicine (AASM) - accredited sleep clinics and one research laboratory. 
      Sixty-three subjects (analysis cohort) were studied from a screening cohort of 
      367 subjects. The analysis cohort was 69.8% men, ages 53.6+/-8.9 years (mean+/-SD), 
      body mass index of 32.3+/-4.5kg/m(2), with mild to severe OSA. At treatment 
      initiation, subjects received random assignment to one night with and one without 
      (control) treatment, and they were assessed again following 28 nights of 
      treatment. Breathing and sleep architecture were assessed each night based on 
      blind scoring by a single centralized scorer using AASM criteria. RESULTS: 
      Average nightly usage across the take-home period was 6.0+/-1.4h. There were no 
      severe or serious device-related adverse events (AEs). Median apnea-hypopnea 
      index (AHI) was 27.5 events per hour on the control night, 13.4 events per hour 
      on the first treatment night, and 14.8 events per hour after 28days of treatment. 
      A clinically significant response (treatment AHI ⩽10/h and ⩽50% of control 
      values) was seen in 20 of the 63 subjects evaluated. Rapid eye movement 
      percentage (REM%) was significantly increased, and N1%, stage shifts to N1 sleep, 
      overall stage shifts, total awakenings, and arousals per hour were all 
      significantly reduced at both treatment nights compared to controls. Mean Epworth 
      sleepiness scale (ESS) was significantly reduced from 12.1 to 8.6 (Cohen d effect 
      size, 0.68) in those untreated for two or more weeks prior to OPT study 
      participation and remained unchanged in subjects who directly switched from 
      continuous positive airway pressure (CPAP) therapy to OPT. CONCLUSION: Clinically 
      significant improvements in sleep quality and continuity, AHI, ODI, ESS, and 
      overall clinical status were achieved in an easily identified subgroup. OPT was 
      safe and well-tolerated and nightly usage was high.
CI  - Copyright (c) 2013 Elsevier B.V. All rights reserved.
FAU - Colrain, Ian M
AU  - Colrain IM
AD  - SRI International, Menlo Park, CA 94025, USA. ian.colrain@sri.com
FAU - Black, Jed
AU  - Black J
FAU - Siegel, Lawrence C
AU  - Siegel LC
FAU - Bogan, Richard K
AU  - Bogan RK
FAU - Becker, Philip M
AU  - Becker PM
FAU - Farid-Moayer, Mehran
AU  - Farid-Moayer M
FAU - Goldberg, Rochelle
AU  - Goldberg R
FAU - Lankford, D Alan
AU  - Lankford DA
FAU - Goldberg, Andrew N
AU  - Goldberg AN
FAU - Malhotra, Atul
AU  - Malhotra A
LA  - eng
GR  - K24 HL093218/HL/NHLBI NIH HHS/United States
GR  - R01 HL085188/HL/NHLBI NIH HHS/United States
GR  - R01 HL090897/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130717
PL  - Netherlands
TA  - Sleep Med
JT  - Sleep medicine
JID - 100898759
SB  - IM
MH  - Adult
MH  - Cross-Over Studies
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Palate, Soft/*physiology
MH  - *Patient Compliance
MH  - Polysomnography
MH  - Pressure
MH  - Prospective Studies
MH  - Sleep Apnea Syndromes/physiopathology/*therapy
MH  - Sleep Apnea, Obstructive/physiopathology/*therapy
MH  - Sleep, REM
MH  - Tongue/*physiology
MH  - Treatment Outcome
MH  - Vacuum
PMC - PMC3932027
MID - NIHMS539304
OTO - NOTNLM
OT  - AHI
OT  - Compliance
OT  - Epworth sleepiness scale
OT  - ODI
OT  - Obstructive sleep apnea
OT  - Oral pressure therapy
COIS- Conflicts of interest Dr Black is a consultant to ApniCure and Dr Siegel is 
      employed by ApniCure.
EDAT- 2013/07/23 06:00
MHDA- 2014/05/13 06:00
PMCR- 2014/03/01
CRDT- 2013/07/23 06:00
PHST- 2012/11/08 00:00 [received]
PHST- 2013/03/14 00:00 [revised]
PHST- 2013/05/07 00:00 [accepted]
PHST- 2013/07/23 06:00 [entrez]
PHST- 2013/07/23 06:00 [pubmed]
PHST- 2014/05/13 06:00 [medline]
PHST- 2014/03/01 00:00 [pmc-release]
AID - S1389-9457(13)00187-1 [pii]
AID - 10.1016/j.sleep.2013.05.009 [doi]
PST - ppublish
SO  - Sleep Med. 2013 Sep;14(9):830-7. doi: 10.1016/j.sleep.2013.05.009. Epub 2013 Jul 
      17.