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Am. J. Respir. Crit. Care Med. · May 2011
Randomized Controlled Trial Clinical TrialNoninferiority of functional outcome in ambulatory management of obstructive sleep apnea.
- Samuel T Kuna, Indira Gurubhagavatula, Greg Maislin, Sakhena Hin, Kathryn C Hartwig, Sue McCloskey, Robert Hachadoorian, Sharon Hurley, Rajesh Gupta, Bethany Staley, and Charles W Atwood.
- VISN 4 Eastern Regional Sleep Center (111P), Department of Medicine, Philadelphia Veterans Affairs Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104, USA.. Samuel.Kuna@va.gov
- Am. J. Respir. Crit. Care Med. 2011 May 1;183(9):1238-44.
RationaleHome portable monitor testing is increasingly being used to diagnose patients with obstructive sleep apnea (OSA) and to initiate them on continuous positive airway pressure (CPAP) treatment.ObjectivesTo compare functional outcome and treatment adherence in patients who receive ambulatory versus in-laboratory testing for OSA.MethodsVeterans with suspected OSA were randomized to either home testing or standard in-laboratory testing. Home testing consisted of a type 3 portable monitor recording followed by at least three nights using an automatically adjusting positive airway pressure apparatus. Participants diagnosed with OSA were treated with CPAP for 3 months.Measurements And Main ResultsWe measured the change in Functional Outcomes of Sleep Questionnaire score, with an a priori noninferiority delta of -1, and the mean daily hours of objectively measured CPAP adherence, with an a priori noninferiority delta of -0.75 hour/day. Of the 296 subjects enrolled, 260 (88%) were diagnosed with OSA, and 213 (75%) were initiated on CPAP. Mean ± SD functional outcome score improved 1.74 ± 2.81 in the home group (P < 0.001) and 1.85 ± 2.46 in the in-laboratory group (P < 0.0001). The lower bound of the one-sided 95% noninferiority confidence interval was -0.54. Mean ± SD hours of daily CPAP adherence were 3.5 ± 2.5 hours/day in the home group and 2.9 ± 2.3 hours/day in the in-laboratory group (P = 0.08). The lower bound of the one-sided 95% noninferiority confidence interval was 0.03.ConclusionsFunctional outcome and treatment adherence in patients evaluated according to a home testing algorithm is not clinically inferior to that in patients receiving standard in-laboratory polysomnography.
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