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

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 › peer-review

38 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 language	English (US)
Pages (from-to)	260-266
Number of pages	7
Journal	Sleep
Volume	33
Issue number	2
State	Published - Feb 1 2010
Externally published	Yes

Keywords

CPAP
Placebo
Polysomnogram
Randomized controlled trial
Sham-CPAP

ASJC Scopus subject areas

Physiology (medical)
Clinical Neurology

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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 › peer-review

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.",

keywords = "CPAP, Placebo, Polysomnogram, Randomized controlled trial, Sham-CPAP",

author = "Rodway, {George W} and Weaver, {Terri E.} and Cristina Mancini and Jacqueline Cater and Greg Maislin and Bethany Staley and Ferguson, {Kathleen A.} and George, {Charles F P} and Schulman, {David A.} and Harly Greenberg and Rapoport, {David M.} and Walsleben, {Joyce A.} and Teofilo Lee-Chiong and Kuna, {Samuel T.}",

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AU - Rodway, George W

AU - Weaver, Terri E.

AU - Mancini, Cristina

AU - Cater, Jacqueline

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.

KW - CPAP

KW - Placebo

KW - Polysomnogram

KW - Randomized controlled trial

KW - Sham-CPAP

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