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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creator | 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 |
description | 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. |
doi_str_mv | 10.1093/sleep/33.2.260 |
format | Article |
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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.</description><identifier>ISSN: 0161-8105</identifier><identifier>EISSN: 1550-9109</identifier><identifier>DOI: 10.1093/sleep/33.2.260</identifier><identifier>PMID: 20175410</identifier><identifier>CODEN: SLEED6</identifier><language>eng</language><publisher>Darien, IL: American Academy of Sleep Medicine</publisher><subject>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</subject><ispartof>Sleep (New York, N.Y.), 2010-02, Vol.33 (2), p.260-266</ispartof><rights>2015 INIST-CNRS</rights><rights>2010 Associated Professional Sleep Societies, LLC.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c419t-42ebed30c67a5bc6c86d11194bc9d154d2a596a22fcbe550b7e9b1ea62fee5cd3</citedby><cites>FETCH-LOGICAL-c419t-42ebed30c67a5bc6c86d11194bc9d154d2a596a22fcbe550b7e9b1ea62fee5cd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22363423$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20175410$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>RODWAY, George W</creatorcontrib><creatorcontrib>WEAVER, Terri E</creatorcontrib><creatorcontrib>RAPOPORT, David M</creatorcontrib><creatorcontrib>WALSLEBEN, Joyce A</creatorcontrib><creatorcontrib>LEE-CHIONG, Teofilo</creatorcontrib><creatorcontrib>KUNA, Samuel T</creatorcontrib><creatorcontrib>MANCINI, Cristina</creatorcontrib><creatorcontrib>CATER, Jacqueline</creatorcontrib><creatorcontrib>MAISLIN, Greg</creatorcontrib><creatorcontrib>STALEY, Bethany</creatorcontrib><creatorcontrib>FERGUSON, Kathleen A</creatorcontrib><creatorcontrib>GEORGE, Charles F. P</creatorcontrib><creatorcontrib>SCHULMAN, David A</creatorcontrib><creatorcontrib>GREENBERG, Harly</creatorcontrib><title>Evaluation of Sham-CPAP as a Placebo in CPAP Intervention Studies</title><title>Sleep (New York, N.Y.)</title><addtitle>Sleep</addtitle><description>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.</description><subject>Adult</subject><subject>Aged</subject><subject>Behavioral psychophysiology</subject><subject>Biological and medical sciences</subject><subject>Continuous Positive Airway Pressure - instrumentation</subject><subject>Equipment Design</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Placebos</subject><subject>Polysomnography</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychology. Psychophysiology</subject><subject>Sham-CPAP as a Placebo</subject><subject>Sleep Apnea, Obstructive - therapy</subject><subject>Sleep Stages</subject><issn>0161-8105</issn><issn>1550-9109</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkMtPwzAMxiMEgvG4ckS9IE7t4qRpmwvSNPGYhMSkwTlyU5cVde1o2kn894QxXifL9s-f7Y-xc-ARcC3HriZaj6WMRCQSvsdGoBQPte_tsxGHBMIMuDpix869cp_HWh6yI8EhVTHwEZvcbLAesK_aJmjLYLHEVTidT-YBugCDeY2W8jaommBbnDU9dRtqtviiH4qK3Ck7KLF2dLaLJ-z59uZpeh8-PN7NppOH0Mag-zAWlFMhuU1SVLlNbJYUAKDj3OoCVFwIVDpBIUqbk_8hT0nnQJiIkkjZQp6w6y_d9ZCvqLD-ig5rs-6qFXbvpsXK_O801dK8tBsjMkg1SC9wtRPo2reBXG9WlbNU19hQOziTSplmKlbak9EXabvWuY7Kny3AzaftZmu7kdII4233Axd_b_vBv332wOUOQGexLjtsbOV-OSETGQspPwAf8Ywi</recordid><startdate>20100201</startdate><enddate>20100201</enddate><creator>RODWAY, George W</creator><creator>WEAVER, Terri E</creator><creator>RAPOPORT, David M</creator><creator>WALSLEBEN, Joyce A</creator><creator>LEE-CHIONG, Teofilo</creator><creator>KUNA, Samuel T</creator><creator>MANCINI, Cristina</creator><creator>CATER, Jacqueline</creator><creator>MAISLIN, Greg</creator><creator>STALEY, Bethany</creator><creator>FERGUSON, Kathleen A</creator><creator>GEORGE, Charles F. 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Psychophysiology</topic><topic>Sham-CPAP as a Placebo</topic><topic>Sleep Apnea, Obstructive - therapy</topic><topic>Sleep Stages</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>RODWAY, George W</creatorcontrib><creatorcontrib>WEAVER, Terri E</creatorcontrib><creatorcontrib>RAPOPORT, David M</creatorcontrib><creatorcontrib>WALSLEBEN, Joyce A</creatorcontrib><creatorcontrib>LEE-CHIONG, Teofilo</creatorcontrib><creatorcontrib>KUNA, Samuel T</creatorcontrib><creatorcontrib>MANCINI, Cristina</creatorcontrib><creatorcontrib>CATER, Jacqueline</creatorcontrib><creatorcontrib>MAISLIN, Greg</creatorcontrib><creatorcontrib>STALEY, Bethany</creatorcontrib><creatorcontrib>FERGUSON, Kathleen A</creatorcontrib><creatorcontrib>GEORGE, Charles F. 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P</au><au>SCHULMAN, David A</au><au>GREENBERG, Harly</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of Sham-CPAP as a Placebo in CPAP Intervention Studies</atitle><jtitle>Sleep (New York, N.Y.)</jtitle><addtitle>Sleep</addtitle><date>2010-02-01</date><risdate>2010</risdate><volume>33</volume><issue>2</issue><spage>260</spage><epage>266</epage><pages>260-266</pages><issn>0161-8105</issn><eissn>1550-9109</eissn><coden>SLEED6</coden><abstract>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.</abstract><cop>Darien, IL</cop><pub>American Academy of Sleep Medicine</pub><pmid>20175410</pmid><doi>10.1093/sleep/33.2.260</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
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 |
title | Evaluation of Sham-CPAP as a Placebo in CPAP Intervention Studies |
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