• George W Rodway, Terri E Weaver, Cristina Mancini, Jacqueline Cater, Greg Maislin, Bethany Staley, Kathleen A Ferguson, Charles F P George, David A Schulman, Harly Greenberg, David M Rapoport, Joyce A Walsleben, Teofilo Lee-Chiong, and Samuel T Kuna.
• University of Utah College of Nursing and School of Medicine, Salt Lake City, UT, USA.
• Sleep. 2010 Feb 1; 33 (2): 260-6.

Study ObjectivesTo evaluate the use of sham-continuous positive airway pressure (CPAP) treatment as a placebo intervention.Design And SettingAnalysis of polysomnograms performed in fixed order without sham-CPAP and on the first night of the sham-CPAP intervention in participants in the CPAP Apnea Trial North American Program (CATNAP), a randomized, placebo controlled trial evaluating the effects of CPAP treatment on daytime function in adults with newly diagnosed mild to moderate obstructive sleep apnea (apnea hypopnea index (AHI) 5-30).ParticipantsThe first 104 CATNAP participants randomized to the sham-CPAP intervention arm.Measurements And ResultsCompared to the polysomnographic measures without sham-CPAP, the study on the first night with sham-CPAP had statistically significant differences that suggested a decrease in sleep quality: decreased sleep efficiency, increased arousal index, increased time in stage 1 NREM sleep, and prolonged latency to REM sleep. However, all of these differences had a relatively small effect size. Compared to the polysomnogram without sham-CPAP, the number of hypopneas on the sham-CPAP polysomnogram was significantly increased and the number of apneas significantly decreased. Relatively minor differences in AHI with and without sham-CPAP were present and were dependent on the criteria used to score hypopneas.ConclusionComparison of polysomnograms with and without sham-CPAP revealed differences that, although statistically significant, were small in magnitude and had relatively low effect sizes suggesting minimal clinical significance. The results support the use of sham-CPAP as a placebo intervention in trials evaluating the effects of CPAP treatment in patients with obstructive sleep apnea.Clinical Trial InformationThis paper was a secondary analysis of clinical trial data. CATNAP: CPAP Apnea Trial North American Program, the trial from which the data were obtained, is registered with clinicaltrial.gov. Registration #NCT00089752.

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