Evaluation of sham-CPAP as a placebo in CPAP intervention studies

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, Samuel T. Kuna

Research output: Contribution to journalArticle

33 Scopus citations

Abstract

Study Objectives: To evaluate the use of sham-continuous positive airway pressure (CPAP) treatment as a placebo intervention. Design and Setting: 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). Participants: The first 104 CATNAP participants randomized to the sham-CPAP intervention arm. Measurements and Results: 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. Conclusion: 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. Clinical Trial Information: 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.

Original languageEnglish (US)
Pages (from-to)260-266
Number of pages7
JournalSleep
Volume33
Issue number2
StatePublished - Feb 1 2010
Externally publishedYes

    Fingerprint

Keywords

  • CPAP
  • Placebo
  • Polysomnogram
  • Randomized controlled trial
  • Sham-CPAP

ASJC Scopus subject areas

  • Physiology (medical)
  • Clinical Neurology

Cite this

Rodway, G. W., Weaver, T. E., Mancini, C., Cater, J., Maislin, G., Staley, B., Ferguson, K. A., George, C. F. P., Schulman, D. A., Greenberg, H., Rapoport, D. M., Walsleben, J. A., Lee-Chiong, T., & Kuna, S. T. (2010). Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Sleep, 33(2), 260-266.