A multicenter, prospective study of a novel nasal EPAP device in the treatment of obstructive sleep apnea: efficacy and 30-day adherence.
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.
Rosenthal
Leon
L
Sleep Medicine Associates of Texas, Dallas, TX, USA. ldr@sleepmed.com
Massie
Clifford A
CA
Dolan
Diana C
DC
Loomas
Bryan
B
Kram
Jerrold
J
Hart
Robert W
RW
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
Laryngoscope. 2000 Mar;110(3 Pt 1):469-75
10718440
Psychiatry Res. 1989 May;28(2):193-213
2748771
Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8
18250209
Am J Respir Crit Care Med. 2002 Jul 15;166(2):159-65
12119227
Am J Respir Crit Care Med. 2001 Oct 15;164(8 Pt 1):1459-63
11704596
Can Respir J. 2008 Oct;15(7):365-9
18949106
Sleep Breath. 2007 Mar;11(1):1-22
17136406
J Clin Sleep Med. 2008 Oct 15;4(5):426-33
18853699
Chest. 2007 Dec;132(6):1847-52
17925415
Sleep. 1991 Dec;14(6):540-5
1798888
Arch Intern Med. 2003 Mar 10;163(5):565-71
12622603
Chest. 2007 Sep;132(3):1057-72
17873201
Laryngoscope. 2007 Oct;117(10):1859-63
17713449
Acta Otolaryngol Suppl. 1996;523:231-3
9082791
Eur Respir J. 2000 Nov;16(5):921-7
11153593
Sleep Med. 2000 Jul 1;1(3):215-220
10828432
Am Rev Respir Dis. 1983 Oct;128(4):708-11
6354028
Laryngoscope. 1985 Jan;95(1):70-4
3965833
Sleep. 2008 Mar;31(3):429-32
18363320
Sleep. 1999 Aug 1;22(5):667-89
10450601