title: A multicenter, prospective study of a novel nasal EPAP device in the treatment of obstructive sleep apnea: efficacy and 30-day adherence.
abstract: OBJECTIVE
  Evaluate the efficacy of a novel device placed in the nares that imposes an expiratory resistance for the treatment of obstructive sleep apnea (OSA) and evaluate adherence to the device over a 30-day in-home trial period.
  
  
  METHODS
  One diagnostic and 3 treatment polysomnograms were administered in a Latin-square design to identify the optimal expiratory resistance to be used during the 30-day in-home trial. Subjects had repeat polysomnography with the prescribed device at the end of the 30-day trial.
  
  
  METHODS
  Multicenter study.
  
  
  METHODS
  Participants (N=34; age 27 to 67) with a baseline apnea-hypopnea index (AHI) > or =5.
  
  
  RESULTS
  The AHI was reduced from 24.5 _ 23.6 (mean +/- SD) to an average of 13.5 +/- 18.7 (p < 0.001) across initial treatment nights. The AHI was 15.5 +/-+/- 18.9 (p = 0.001) for the prescribed device at the end of the 30-day trial. Of 24 subjects with an AHI > 10 at baseline, 13 achieved an AHI < 10 on the initial treatment nights; 10 had a similar response on the final treatment night. Percent of the night snoring decreased from 27.5 +/- 23.2 to 11.6 +/- 13.7 (p < 0.001) on initial treatment nights and 14.6 +/- 20.6 (p = 0.013) at the end of the trial; Epworth Sleepiness scores decreased from 8.7 +/- 4.0 at baseline to 6.9 +/- 4.4 (p < 0.001) at the end of the trial; the Pittsburgh Sleep Quality Index improved from 7.4 +/- 3.3 to 6.5 +/- 3.6 (p = 0.042). Mean oxygen saturation increased from 94.8 +/- 2.0 to 95.2 +/- 1.9 (p = 0.023) on initial treatment nights and 95.3 +/- 1.9 (p = 0.003) at the end of the trial. Sleep architecture was not affected. Participants reported using the device all night long for 94% of nights during the in-home trial.
  
  
  CONCLUSIONS
  Treatment with this novel device was well tolerated and accepted by the participants. An overall reduction in AHI was documented; however, therapeutic response was variable among the participants. Further research is required to identify the ideal candidates for this new therapeutic option in the management of OSA.
authors.affiliation: Sleep Medicine Associates of Texas, Dallas, TX, USA. ldr@sleepmed.com
authors.forename: Leon
authors.initials: L
authors.lastname: Rosenthal
authors.forename: Clifford A
authors.initials: CA
authors.lastname: Massie
authors.forename: Diana C
authors.initials: DC
authors.lastname: Dolan
authors.forename: Bryan
authors.initials: B
authors.lastname: Loomas
authors.forename: Jerrold
authors.initials: J
authors.lastname: Kram
authors.forename: Robert W
authors.initials: RW
authors.lastname: Hart
mesh_terms: D000328:Adult; D000368:Aged; D000403:Airway Resistance; D004867:Equipment Design; D045853:Exhalation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009296:Nasal Cavity; D010349:Patient Compliance / Q000706:statistics & numerical data*; D017286:Polysomnography / Q000379:methods / Q000706:statistics & numerical data; D011175:Positive-Pressure Respiration / Q000295:instrumentation* / Q000379:methods; D011446:Prospective Studies; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D016896:Treatment Outcome
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