BACKGROUND: Home diagnosis and therapy for obstructive sleep apnea (OSA) may improve access to testing and continuous positive airway pressure (CPAP) treatment. We compared subjective sleepiness, sleep quality, quality of life, BP, and CPAP adherence after 4 weeks of CPAP therapy in subjects in whom OSA was diagnosed and treated at home and in those evaluated in the sleep laboratory. METHODS: A randomized trial was performed consisting of home-based level 3 testing followed by 1 week of auto-CPAP and fixed-pressure CPAP based on the 95% pressure derived from the auto-CPAP device, and in-laboratory polysomnography (PSG) (using mostly split-night protocol) with CPAP titration; 102 subjects were randomized (age, 47.4 +/- 11.4 years; 63 men; BMI, 32.3 +/- 6.3 kg/m(2); Epworth Sleepiness Scale [ESS]: 12.5 +/- 4.3). The outcome measures were daytime sleepiness (ESS), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), quality of life (Calgary Sleep Apnea Quality of Life Index [SAQLI], 36-Item Short-Form Health Survey [SF-36], BP, and CPAP adherence after 4 weeks. RESULTS: After 4 weeks of CPAP therapy, there were no significant differences in ESS (PSG 6.4 +/- 3.8 vs home monitoring [HM] 6.5 +/- 3.8, P = .71), PSQI (PSG 5.4 +/- 3.1 vs HM 6.2 +/- 3.4, P = .30), SAQLI (PSG 4.5 +/- 1.1 vs HM 4.6 +/- 1.1, P = .85), SF-36 vitality (PSG 62.2 +/- 23.3 vs HM 64.1 +/- 18.4, P = .79), SF-36 HM (PSG 84.0 +/- 10.4 vs HM 81.3 +/- 14.9, P = .39), and BP (PSG 129/84 +/- 11/0 vs HM 125/81 +/- 13/9, P = .121). There was no difference in CPAP adherence (PSG 5.6 +/- 1.7 h/night vs HM 5.4 +/- 1.0 h/night, P = .49). CONCLUSIONS: Compared with the home-based protocol, diagnosis and treatment of OSA in the sleep laboratory does not lead to superior 4-week outcomes in sleepiness scores, sleep quality, quality of life, BP, and CPAP adherence. TRIAL REGISTRATION: clinicaltrials.gov; Identifier: NCT00139022.
RCT Entities:
BACKGROUND: Home diagnosis and therapy for obstructive sleep apnea (OSA) may improve access to testing and continuous positive airway pressure (CPAP) treatment. We compared subjective sleepiness, sleep quality, quality of life, BP, and CPAP adherence after 4 weeks of CPAP therapy in subjects in whom OSA was diagnosed and treated at home and in those evaluated in the sleep laboratory. METHODS: A randomized trial was performed consisting of home-based level 3 testing followed by 1 week of auto-CPAP and fixed-pressure CPAP based on the 95% pressure derived from the auto-CPAP device, and in-laboratory polysomnography (PSG) (using mostly split-night protocol) with CPAP titration; 102 subjects were randomized (age, 47.4 +/- 11.4 years; 63 men; BMI, 32.3 +/- 6.3 kg/m(2); Epworth Sleepiness Scale [ESS]: 12.5 +/- 4.3). The outcome measures were daytime sleepiness (ESS), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), quality of life (Calgary Sleep Apnea Quality of Life Index [SAQLI], 36-Item Short-Form Health Survey [SF-36], BP, and CPAP adherence after 4 weeks. RESULTS: After 4 weeks of CPAP therapy, there were no significant differences in ESS (PSG 6.4 +/- 3.8 vs home monitoring [HM] 6.5 +/- 3.8, P = .71), PSQI (PSG 5.4 +/- 3.1 vs HM 6.2 +/- 3.4, P = .30), SAQLI (PSG 4.5 +/- 1.1 vs HM 4.6 +/- 1.1, P = .85), SF-36 vitality (PSG 62.2 +/- 23.3 vs HM 64.1 +/- 18.4, P = .79), SF-36 HM (PSG 84.0 +/- 10.4 vs HM 81.3 +/- 14.9, P = .39), and BP (PSG 129/84 +/- 11/0 vs HM 125/81 +/- 13/9, P = .121). There was no difference in CPAP adherence (PSG 5.6 +/- 1.7 h/night vs HM 5.4 +/- 1.0 h/night, P = .49). CONCLUSIONS: Compared with the home-based protocol, diagnosis and treatment of OSA in the sleep laboratory does not lead to superior 4-week outcomes in sleepiness scores, sleep quality, quality of life, BP, and CPAP adherence. TRIAL REGISTRATION: clinicaltrials.gov; Identifier: NCT00139022.
Authors: Nancy A Collop; Sharon L Tracy; Vishesh Kapur; Reena Mehra; David Kuhlmann; Sam A Fleishman; Joseph M Ojile Journal: J Clin Sleep Med Date: 2011-10-15 Impact factor: 4.062
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