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 journal › Article

33 Citations (Scopus)

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

Continuous Positive Airway Pressure
Placebos
Apnea
Sleep
Obstructive Sleep Apnea
Clinical Trials
REM Sleep
Arousal

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., ... Kuna, S. T. (2010). Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Sleep, 33(2), 260-266.

Evaluation of sham-CPAP as a placebo in CPAP intervention studies. / Rodway, George W; Weaver, Terri E.; Mancini, Cristina; Cater, Jacqueline; Maislin, Greg; Staley, Bethany; Ferguson, Kathleen A.; George, Charles F P; Schulman, David A.; Greenberg, Harly; Rapoport, David M.; Walsleben, Joyce A.; Lee-Chiong, Teofilo; Kuna, Samuel T.

In: Sleep, Vol. 33, No. 2, 01.02.2010, p. 260-266.

Research output: Contribution to journal › Article

Rodway, GW, Weaver, TE, Mancini, C, Cater, J, Maislin, G, Staley, B, Ferguson, KA, George, CFP, Schulman, DA, Greenberg, H, Rapoport, DM, Walsleben, JA, Lee-Chiong, T & Kuna, ST 2010, 'Evaluation of sham-CPAP as a placebo in CPAP intervention studies', Sleep, vol. 33, no. 2, pp. 260-266.
Rodway GW, Weaver TE, Mancini C, Cater J, Maislin G, Staley B et al. Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Sleep. 2010 Feb 1;33(2):260-266.
Rodway, George W ; Weaver, Terri E. ; Mancini, Cristina ; Cater, Jacqueline ; Maislin, Greg ; Staley, Bethany ; Ferguson, Kathleen A. ; George, Charles F P ; Schulman, David A. ; Greenberg, Harly ; Rapoport, David M. ; Walsleben, Joyce A. ; Lee-Chiong, Teofilo ; Kuna, Samuel T. / Evaluation of sham-CPAP as a placebo in CPAP intervention studies. In: Sleep. 2010 ; Vol. 33, No. 2. pp. 260-266.
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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.",
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AU - Maislin, Greg

AU - Staley, Bethany

AU - Ferguson, Kathleen A.

AU - George, Charles F P

AU - Schulman, David A.

AU - Greenberg, Harly

AU - Rapoport, David M.

AU - Walsleben, Joyce A.

AU - Lee-Chiong, Teofilo

AU - Kuna, Samuel T.

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N2 - 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.

AB - 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.

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