Evaluation of Sham-CPAP as a Placebo in CPAP Intervention Studies

To evaluate the use of sham-continuous positive airway pressure (CPAP) treatment as a placebo intervention. Analysis 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 (CATNA...

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Published in:Sleep (New York, N.Y.) N.Y.), 2010-02, Vol.33 (2), p.260-266
Main Authors: RODWAY, George W, WEAVER, Terri E, RAPOPORT, David M, WALSLEBEN, Joyce A, LEE-CHIONG, Teofilo, KUNA, Samuel T, MANCINI, Cristina, CATER, Jacqueline, MAISLIN, Greg, STALEY, Bethany, FERGUSON, Kathleen A, GEORGE, Charles F. P, SCHULMAN, David A, GREENBERG, Harly
Format: Article
Language:English
Subjects:
Adult
Aged
Behavioral psychophysiology
Biological and medical sciences
Continuous Positive Airway Pressure - instrumentation
Equipment Design
Female
Fundamental and applied biological sciences. Psychology
Humans
Male
Middle Aged
Placebos
Polysomnography
Psychology. Psychoanalysis. Psychiatry
Psychology. Psychophysiology
Sham-CPAP as a Placebo
Sleep Apnea, Obstructive - therapy
Sleep Stages
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Summary:To evaluate the use of sham-continuous positive airway pressure (CPAP) treatment as a placebo intervention. Analysis 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). The first 104 CATNAP participants randomized to the sham-CPAP intervention arm. Compared 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. Comparison 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. This 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.
ISSN:0161-8105
1550-9109
DOI:10.1093/sleep/33.2.260