Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial
Abstract Study Objective Treatment of sleep-disordered breathing (SDB) with positive airway pressure (PAP) therapy has unique clinical challenges in individuals living with spinal cord injuries and diseases (spinal cord injury [SCI]/D). Interventions focused on increasing PAP use have not been studi...
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| Veröffentlicht in: | Sleep (New York, N.Y.) N.Y.), 2024-05, Vol.47 (5), p.1 |
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| creator | Badr, M Safwan Martin, Jennifer L Sankari, Abdulghani Zeineddine, Salam Salloum, Anan Henzel, M Kristina Strohl, Kingman Shamim-Uzzaman, Afifa May, Anna M Fung, Constance H Pandya, Nishtha Carroll, Sean Mitchell, Michael N |
| description | Abstract
Study Objective
Treatment of sleep-disordered breathing (SDB) with positive airway pressure (PAP) therapy has unique clinical challenges in individuals living with spinal cord injuries and diseases (spinal cord injury [SCI]/D). Interventions focused on increasing PAP use have not been studied in this population. We aimed to evaluate the benefits of a program to increase PAP use among Veterans with SCI/D and SDB.
Methods
Randomized controlled trial comparing a behavioral Intervention (n = 32) and educational control (n = 31), both including one face-to-face and five telephone sessions over 3 months. The intervention included education about SDB and PAP, goal setting, troubleshooting, and motivational enhancement. The control arm included non-directive sleep education only.
Results
Primary outcomes were objective PAP use (nights ≥4 hours used within 90 days) and sleep quality (Pittsburgh Sleep Quality Index [PSQI] at 3 months). These did not differ between intervention and control (main outcome timepoint; mean difference 3.5 [−9.0, 15.9] nights/week for PAP use; p = .578; −1.1 [−2.8, 0.6] points for PSQI; p = .219). Secondary outcomes included fatigue, depression, function, and quality of life. Only fatigue improved significantly more in the intervention versus the control group (p = .025). Across groups, more PAP use was associated with larger improvements in sleep quality, insomnia, sleepiness, fatigue, and depression at some time points.
Conclusions
PAP use in Veterans with SCI/D and SDB is low, and a 3-month supportive/behavioral program did not show significant benefit compared to education alone. Overall, more PAP use was associated with improved symptoms suggesting more intensive support, such as in-home assistance, may be required to increase PAP use in these patients.
Clinical Trials Information
Title: “Treatment of Sleep Disordered Breathing in Patients with SCI.” Registration number: NCT02830074. Website: https://clinicaltrials.gov/study/NCT02830074?cond=Sleep%20Apnea&term=badr&rank=5
Graphical Abstract
Graphical Abstract |
| doi_str_mv | 10.1093/sleep/zsae044 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11494382</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A795613814</galeid><oup_id>10.1093/sleep/zsae044</oup_id><sourcerecordid>A795613814</sourcerecordid><originalsourceid>FETCH-LOGICAL-c477t-1d047c2834940fcff4408e7f24d5d1559b3c896a826fdfb313b3400ad10a2a363</originalsourceid><addsrcrecordid>eNqFksuLFDEQxoMo7jh69CoBL156J69-eZFl8bGw4EXPIZNU1gzdSZvqXpn56826464rguRQVOpXX1HFR8hLzk456-UGB4Bpc0ADTKlHZMXrmlV9KT0mK8YbXnWc1SfkGeKOlVz18ik5kZ0SQrb1ihwu4gwRwzVQXKYp5Zm6BEhjmmkYp5xKYUoY5kJUJuQfZk-nDIhLBrog0BApTiGagdqUXUl3S95vXEAwCG-podlEl8ZwAEftEGKwBZ1zMMNz8sSbAeHFMa7J1w_vv5x_qi4_f7w4P7usrGrbueKOqdaKTqpeMW-9V4p10HqhXO3Ktv1W2q5vTCca7_xWcrmVijHjODPCyEauybtb3WnZjuAsxDmbQU85jCbvdTJBP6zE8E1fpWvNeRkpO1EU3hwVcvq-AM56DGhhGEyEtKAWvVSi6ZsS1-T1X-guLbmcB7XkomO8VbW8p67MADpEn8pgeyOqz9q-brjsuCrU6T-o8hyMwaYIPpT_Bw3VbYPNCTGDv1uSM33jFv3LLfrolsK_-vMyd_Rve9wvnpbpP1o_AW-WzDs</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3128017453</pqid></control><display><type>article</type><title>Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial</title><source>MEDLINE</source><source>Oxford Journals Online</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><creator>Badr, M Safwan ; Martin, Jennifer L ; Sankari, Abdulghani ; Zeineddine, Salam ; Salloum, Anan ; Henzel, M Kristina ; Strohl, Kingman ; Shamim-Uzzaman, Afifa ; May, Anna M ; Fung, Constance H ; Pandya, Nishtha ; Carroll, Sean ; Mitchell, Michael N</creator><creatorcontrib>Badr, M Safwan ; Martin, Jennifer L ; Sankari, Abdulghani ; Zeineddine, Salam ; Salloum, Anan ; Henzel, M Kristina ; Strohl, Kingman ; Shamim-Uzzaman, Afifa ; May, Anna M ; Fung, Constance H ; Pandya, Nishtha ; Carroll, Sean ; Mitchell, Michael N</creatorcontrib><description>Abstract
Study Objective
Treatment of sleep-disordered breathing (SDB) with positive airway pressure (PAP) therapy has unique clinical challenges in individuals living with spinal cord injuries and diseases (spinal cord injury [SCI]/D). Interventions focused on increasing PAP use have not been studied in this population. We aimed to evaluate the benefits of a program to increase PAP use among Veterans with SCI/D and SDB.
Methods
Randomized controlled trial comparing a behavioral Intervention (n = 32) and educational control (n = 31), both including one face-to-face and five telephone sessions over 3 months. The intervention included education about SDB and PAP, goal setting, troubleshooting, and motivational enhancement. The control arm included non-directive sleep education only.
Results
Primary outcomes were objective PAP use (nights ≥4 hours used within 90 days) and sleep quality (Pittsburgh Sleep Quality Index [PSQI] at 3 months). These did not differ between intervention and control (main outcome timepoint; mean difference 3.5 [−9.0, 15.9] nights/week for PAP use; p = .578; −1.1 [−2.8, 0.6] points for PSQI; p = .219). Secondary outcomes included fatigue, depression, function, and quality of life. Only fatigue improved significantly more in the intervention versus the control group (p = .025). Across groups, more PAP use was associated with larger improvements in sleep quality, insomnia, sleepiness, fatigue, and depression at some time points.
Conclusions
PAP use in Veterans with SCI/D and SDB is low, and a 3-month supportive/behavioral program did not show significant benefit compared to education alone. Overall, more PAP use was associated with improved symptoms suggesting more intensive support, such as in-home assistance, may be required to increase PAP use in these patients.
Clinical Trials Information
Title: “Treatment of Sleep Disordered Breathing in Patients with SCI.” Registration number: NCT02830074. Website: https://clinicaltrials.gov/study/NCT02830074?cond=Sleep%20Apnea&term=badr&rank=5
Graphical Abstract
Graphical Abstract</description><identifier>ISSN: 0161-8105</identifier><identifier>ISSN: 1550-9109</identifier><identifier>EISSN: 1550-9109</identifier><identifier>DOI: 10.1093/sleep/zsae044</identifier><identifier>PMID: 38422375</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Adult ; Behavior Therapy - methods ; Clinical trials ; Continuous Positive Airway Pressure - methods ; Education ; Fatigue ; Female ; Humans ; Insomnia ; Intervention ; Male ; Medical research ; Medicine, Experimental ; Middle Aged ; Patient compliance ; Patient Education as Topic - methods ; Sleep ; Sleep Apnea Syndromes - complications ; Sleep Apnea Syndromes - therapy ; Sleep Disordered Breathing ; Sleep Quality ; Spinal cord injuries ; Spinal Cord Injuries - complications ; Spinal Cord Injuries - therapy ; Treatment Outcome ; Veterans - statistics & numerical data ; Web sites</subject><ispartof>Sleep (New York, N.Y.), 2024-05, Vol.47 (5), p.1</ispartof><rights>Published by Oxford University Press on behalf of Sleep Research Society (SRS) 2024. 2024</rights><rights>Published by Oxford University Press on behalf of Sleep Research Society (SRS) 2024.</rights><rights>COPYRIGHT 2024 Oxford University Press</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c477t-1d047c2834940fcff4408e7f24d5d1559b3c896a826fdfb313b3400ad10a2a363</citedby><cites>FETCH-LOGICAL-c477t-1d047c2834940fcff4408e7f24d5d1559b3c896a826fdfb313b3400ad10a2a363</cites><orcidid>0000-0001-5769-5243 ; 0000-0002-0181-0086 ; 0000-0002-2400-3375 ; 0000-0002-0140-7932 ; 0000-0002-8382-574X ; 0000-0003-0849-3391</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1583,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38422375$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Badr, M Safwan</creatorcontrib><creatorcontrib>Martin, Jennifer L</creatorcontrib><creatorcontrib>Sankari, Abdulghani</creatorcontrib><creatorcontrib>Zeineddine, Salam</creatorcontrib><creatorcontrib>Salloum, Anan</creatorcontrib><creatorcontrib>Henzel, M Kristina</creatorcontrib><creatorcontrib>Strohl, Kingman</creatorcontrib><creatorcontrib>Shamim-Uzzaman, Afifa</creatorcontrib><creatorcontrib>May, Anna M</creatorcontrib><creatorcontrib>Fung, Constance H</creatorcontrib><creatorcontrib>Pandya, Nishtha</creatorcontrib><creatorcontrib>Carroll, Sean</creatorcontrib><creatorcontrib>Mitchell, Michael N</creatorcontrib><title>Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial</title><title>Sleep (New York, N.Y.)</title><addtitle>Sleep</addtitle><description>Abstract
Study Objective
Treatment of sleep-disordered breathing (SDB) with positive airway pressure (PAP) therapy has unique clinical challenges in individuals living with spinal cord injuries and diseases (spinal cord injury [SCI]/D). Interventions focused on increasing PAP use have not been studied in this population. We aimed to evaluate the benefits of a program to increase PAP use among Veterans with SCI/D and SDB.
Methods
Randomized controlled trial comparing a behavioral Intervention (n = 32) and educational control (n = 31), both including one face-to-face and five telephone sessions over 3 months. The intervention included education about SDB and PAP, goal setting, troubleshooting, and motivational enhancement. The control arm included non-directive sleep education only.
Results
Primary outcomes were objective PAP use (nights ≥4 hours used within 90 days) and sleep quality (Pittsburgh Sleep Quality Index [PSQI] at 3 months). These did not differ between intervention and control (main outcome timepoint; mean difference 3.5 [−9.0, 15.9] nights/week for PAP use; p = .578; −1.1 [−2.8, 0.6] points for PSQI; p = .219). Secondary outcomes included fatigue, depression, function, and quality of life. Only fatigue improved significantly more in the intervention versus the control group (p = .025). Across groups, more PAP use was associated with larger improvements in sleep quality, insomnia, sleepiness, fatigue, and depression at some time points.
Conclusions
PAP use in Veterans with SCI/D and SDB is low, and a 3-month supportive/behavioral program did not show significant benefit compared to education alone. Overall, more PAP use was associated with improved symptoms suggesting more intensive support, such as in-home assistance, may be required to increase PAP use in these patients.
Clinical Trials Information
Title: “Treatment of Sleep Disordered Breathing in Patients with SCI.” Registration number: NCT02830074. Website: https://clinicaltrials.gov/study/NCT02830074?cond=Sleep%20Apnea&term=badr&rank=5
Graphical Abstract
Graphical Abstract</description><subject>Adult</subject><subject>Behavior Therapy - methods</subject><subject>Clinical trials</subject><subject>Continuous Positive Airway Pressure - methods</subject><subject>Education</subject><subject>Fatigue</subject><subject>Female</subject><subject>Humans</subject><subject>Insomnia</subject><subject>Intervention</subject><subject>Male</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Middle Aged</subject><subject>Patient compliance</subject><subject>Patient Education as Topic - methods</subject><subject>Sleep</subject><subject>Sleep Apnea Syndromes - complications</subject><subject>Sleep Apnea Syndromes - therapy</subject><subject>Sleep Disordered Breathing</subject><subject>Sleep Quality</subject><subject>Spinal cord injuries</subject><subject>Spinal Cord Injuries - complications</subject><subject>Spinal Cord Injuries - therapy</subject><subject>Treatment Outcome</subject><subject>Veterans - statistics & numerical data</subject><subject>Web sites</subject><issn>0161-8105</issn><issn>1550-9109</issn><issn>1550-9109</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFksuLFDEQxoMo7jh69CoBL156J69-eZFl8bGw4EXPIZNU1gzdSZvqXpn56826464rguRQVOpXX1HFR8hLzk456-UGB4Bpc0ADTKlHZMXrmlV9KT0mK8YbXnWc1SfkGeKOlVz18ik5kZ0SQrb1ihwu4gwRwzVQXKYp5Zm6BEhjmmkYp5xKYUoY5kJUJuQfZk-nDIhLBrog0BApTiGagdqUXUl3S95vXEAwCG-podlEl8ZwAEftEGKwBZ1zMMNz8sSbAeHFMa7J1w_vv5x_qi4_f7w4P7usrGrbueKOqdaKTqpeMW-9V4p10HqhXO3Ktv1W2q5vTCca7_xWcrmVijHjODPCyEauybtb3WnZjuAsxDmbQU85jCbvdTJBP6zE8E1fpWvNeRkpO1EU3hwVcvq-AM56DGhhGEyEtKAWvVSi6ZsS1-T1X-guLbmcB7XkomO8VbW8p67MADpEn8pgeyOqz9q-brjsuCrU6T-o8hyMwaYIPpT_Bw3VbYPNCTGDv1uSM33jFv3LLfrolsK_-vMyd_Rve9wvnpbpP1o_AW-WzDs</recordid><startdate>20240510</startdate><enddate>20240510</enddate><creator>Badr, M Safwan</creator><creator>Martin, Jennifer L</creator><creator>Sankari, Abdulghani</creator><creator>Zeineddine, Salam</creator><creator>Salloum, Anan</creator><creator>Henzel, M Kristina</creator><creator>Strohl, Kingman</creator><creator>Shamim-Uzzaman, Afifa</creator><creator>May, Anna M</creator><creator>Fung, Constance H</creator><creator>Pandya, Nishtha</creator><creator>Carroll, Sean</creator><creator>Mitchell, Michael N</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-5769-5243</orcidid><orcidid>https://orcid.org/0000-0002-0181-0086</orcidid><orcidid>https://orcid.org/0000-0002-2400-3375</orcidid><orcidid>https://orcid.org/0000-0002-0140-7932</orcidid><orcidid>https://orcid.org/0000-0002-8382-574X</orcidid><orcidid>https://orcid.org/0000-0003-0849-3391</orcidid></search><sort><creationdate>20240510</creationdate><title>Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial</title><author>Badr, M Safwan ; Martin, Jennifer L ; Sankari, Abdulghani ; Zeineddine, Salam ; Salloum, Anan ; Henzel, M Kristina ; Strohl, Kingman ; Shamim-Uzzaman, Afifa ; May, Anna M ; Fung, Constance H ; Pandya, Nishtha ; Carroll, Sean ; Mitchell, Michael N</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c477t-1d047c2834940fcff4408e7f24d5d1559b3c896a826fdfb313b3400ad10a2a363</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Behavior Therapy - methods</topic><topic>Clinical trials</topic><topic>Continuous Positive Airway Pressure - methods</topic><topic>Education</topic><topic>Fatigue</topic><topic>Female</topic><topic>Humans</topic><topic>Insomnia</topic><topic>Intervention</topic><topic>Male</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Middle Aged</topic><topic>Patient compliance</topic><topic>Patient Education as Topic - methods</topic><topic>Sleep</topic><topic>Sleep Apnea Syndromes - complications</topic><topic>Sleep Apnea Syndromes - therapy</topic><topic>Sleep Disordered Breathing</topic><topic>Sleep Quality</topic><topic>Spinal cord injuries</topic><topic>Spinal Cord Injuries - complications</topic><topic>Spinal Cord Injuries - therapy</topic><topic>Treatment Outcome</topic><topic>Veterans - statistics & numerical data</topic><topic>Web sites</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Badr, M Safwan</creatorcontrib><creatorcontrib>Martin, Jennifer L</creatorcontrib><creatorcontrib>Sankari, Abdulghani</creatorcontrib><creatorcontrib>Zeineddine, Salam</creatorcontrib><creatorcontrib>Salloum, Anan</creatorcontrib><creatorcontrib>Henzel, M Kristina</creatorcontrib><creatorcontrib>Strohl, Kingman</creatorcontrib><creatorcontrib>Shamim-Uzzaman, Afifa</creatorcontrib><creatorcontrib>May, Anna M</creatorcontrib><creatorcontrib>Fung, Constance H</creatorcontrib><creatorcontrib>Pandya, Nishtha</creatorcontrib><creatorcontrib>Carroll, Sean</creatorcontrib><creatorcontrib>Mitchell, Michael N</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Sleep (New York, N.Y.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Badr, M Safwan</au><au>Martin, Jennifer L</au><au>Sankari, Abdulghani</au><au>Zeineddine, Salam</au><au>Salloum, Anan</au><au>Henzel, M Kristina</au><au>Strohl, Kingman</au><au>Shamim-Uzzaman, Afifa</au><au>May, Anna M</au><au>Fung, Constance H</au><au>Pandya, Nishtha</au><au>Carroll, Sean</au><au>Mitchell, Michael N</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial</atitle><jtitle>Sleep (New York, N.Y.)</jtitle><addtitle>Sleep</addtitle><date>2024-05-10</date><risdate>2024</risdate><volume>47</volume><issue>5</issue><spage>1</spage><pages>1-</pages><issn>0161-8105</issn><issn>1550-9109</issn><eissn>1550-9109</eissn><abstract>Abstract
Study Objective
Treatment of sleep-disordered breathing (SDB) with positive airway pressure (PAP) therapy has unique clinical challenges in individuals living with spinal cord injuries and diseases (spinal cord injury [SCI]/D). Interventions focused on increasing PAP use have not been studied in this population. We aimed to evaluate the benefits of a program to increase PAP use among Veterans with SCI/D and SDB.
Methods
Randomized controlled trial comparing a behavioral Intervention (n = 32) and educational control (n = 31), both including one face-to-face and five telephone sessions over 3 months. The intervention included education about SDB and PAP, goal setting, troubleshooting, and motivational enhancement. The control arm included non-directive sleep education only.
Results
Primary outcomes were objective PAP use (nights ≥4 hours used within 90 days) and sleep quality (Pittsburgh Sleep Quality Index [PSQI] at 3 months). These did not differ between intervention and control (main outcome timepoint; mean difference 3.5 [−9.0, 15.9] nights/week for PAP use; p = .578; −1.1 [−2.8, 0.6] points for PSQI; p = .219). Secondary outcomes included fatigue, depression, function, and quality of life. Only fatigue improved significantly more in the intervention versus the control group (p = .025). Across groups, more PAP use was associated with larger improvements in sleep quality, insomnia, sleepiness, fatigue, and depression at some time points.
Conclusions
PAP use in Veterans with SCI/D and SDB is low, and a 3-month supportive/behavioral program did not show significant benefit compared to education alone. Overall, more PAP use was associated with improved symptoms suggesting more intensive support, such as in-home assistance, may be required to increase PAP use in these patients.
Clinical Trials Information
Title: “Treatment of Sleep Disordered Breathing in Patients with SCI.” Registration number: NCT02830074. Website: https://clinicaltrials.gov/study/NCT02830074?cond=Sleep%20Apnea&term=badr&rank=5
Graphical Abstract
Graphical Abstract</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>38422375</pmid><doi>10.1093/sleep/zsae044</doi><orcidid>https://orcid.org/0000-0001-5769-5243</orcidid><orcidid>https://orcid.org/0000-0002-0181-0086</orcidid><orcidid>https://orcid.org/0000-0002-2400-3375</orcidid><orcidid>https://orcid.org/0000-0002-0140-7932</orcidid><orcidid>https://orcid.org/0000-0002-8382-574X</orcidid><orcidid>https://orcid.org/0000-0003-0849-3391</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Sleep (New York, N.Y.), 2024-05, Vol.47 (5), p.1 |
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| language | eng |
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| source | MEDLINE; Oxford Journals Online; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Adult Behavior Therapy - methods Clinical trials Continuous Positive Airway Pressure - methods Education Fatigue Female Humans Insomnia Intervention Male Medical research Medicine, Experimental Middle Aged Patient compliance Patient Education as Topic - methods Sleep Sleep Apnea Syndromes - complications Sleep Apnea Syndromes - therapy Sleep Disordered Breathing Sleep Quality Spinal cord injuries Spinal Cord Injuries - complications Spinal Cord Injuries - therapy Treatment Outcome Veterans - statistics & numerical data Web sites |
| title | Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial |
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