Longitudinal comparison study of pressure relief (C-Flex™) vs. CPAP in OSA patients

Background Continuous positive airway pressure (CPAP) devices with the option of flexible pressure delivery (e.g., C-Flex) are thought to provide an improved degree of comfort and result in better therapeutic adherence while maintaining standard CPAP efficacy. The purpose of this study was to compar...

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Veröffentlicht in:Sleep & breathing 2009-02, Vol.13 (1), p.73-77
Hauptverfasser: Dolan, Diana C., Okonkwo, Renata, Gfullner, Florian, Hansbrough, J. Randall, Strobel, Richard J., Rosenthal, Leon
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container_end_page 77
container_issue 1
container_start_page 73
container_title Sleep & breathing
container_volume 13
creator Dolan, Diana C.
Okonkwo, Renata
Gfullner, Florian
Hansbrough, J. Randall
Strobel, Richard J.
Rosenthal, Leon
description Background Continuous positive airway pressure (CPAP) devices with the option of flexible pressure delivery (e.g., C-Flex) are thought to provide an improved degree of comfort and result in better therapeutic adherence while maintaining standard CPAP efficacy. The purpose of this study was to compare adherence and subjective measures of comfort between C-Flex and CPAP treatment. Methods The study was an international, multisite, single-blinded study with participants randomized to either C-Flex or CPAP. Participants completed subjective measures of sleepiness and comfort at baseline, and at 30-, 90-, and 180-day follow-ups. Additionally, compliance data were downloaded from the device at each follow-up. Repeated measures analysis of variance was used to assess the effects of treatment. Results There were 138 men and 46 women (average age of 48 ± 9.2, average Epworth Sleepiness Scale score of 14.9 ± 3.6, and average diagnostic apnea/hypopnea index (AHI) of 51.9 ± 27.7). C-Flex and CPAP groups were comparable on baseline measures, achieved comparable AHI on titration, and had comparable PAP pressure requirements. C-Flex users had comparable average hours of use per night and total nights of use across the study, but had a trend ( p < .07) toward achieving greater total hours of utilization. While both groups had comparable decreases in sleepiness, C-Flex users reported on visual analog scales greater comfort (64.3 vs. 57.4; p = .01). Conclusions The results of this study demonstrated that C-Flex has comparable resolution of respiratory indices and adherence. Furthermore, C-Flex users reported greater mask comfort.
doi_str_mv 10.1007/s11325-008-0199-1
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Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis ; Nervous system (semeiology, syndromes) ; Neurology ; Original Article ; Otorhinolaryngology ; Patient Compliance ; Pediatrics ; Pneumology/Respiratory System ; Polysomnography ; Pressure ; Prospective Studies ; Single-Blind Method ; Sleep Apnea, Obstructive - complications ; Sleep Apnea, Obstructive - diagnosis ; Sleep Apnea, Obstructive - therapy ; Sleep. 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Randall</creatorcontrib><creatorcontrib>Strobel, Richard J.</creatorcontrib><creatorcontrib>Rosenthal, Leon</creatorcontrib><title>Longitudinal comparison study of pressure relief (C-Flex™) vs. CPAP in OSA patients</title><title>Sleep &amp; breathing</title><addtitle>Sleep Breath</addtitle><addtitle>Sleep Breath</addtitle><description>Background Continuous positive airway pressure (CPAP) devices with the option of flexible pressure delivery (e.g., C-Flex) are thought to provide an improved degree of comfort and result in better therapeutic adherence while maintaining standard CPAP efficacy. The purpose of this study was to compare adherence and subjective measures of comfort between C-Flex and CPAP treatment. Methods The study was an international, multisite, single-blinded study with participants randomized to either C-Flex or CPAP. Participants completed subjective measures of sleepiness and comfort at baseline, and at 30-, 90-, and 180-day follow-ups. Additionally, compliance data were downloaded from the device at each follow-up. Repeated measures analysis of variance was used to assess the effects of treatment. Results There were 138 men and 46 women (average age of 48 ± 9.2, average Epworth Sleepiness Scale score of 14.9 ± 3.6, and average diagnostic apnea/hypopnea index (AHI) of 51.9 ± 27.7). C-Flex and CPAP groups were comparable on baseline measures, achieved comparable AHI on titration, and had comparable PAP pressure requirements. C-Flex users had comparable average hours of use per night and total nights of use across the study, but had a trend ( p &lt; .07) toward achieving greater total hours of utilization. While both groups had comparable decreases in sleepiness, C-Flex users reported on visual analog scales greater comfort (64.3 vs. 57.4; p = .01). Conclusions The results of this study demonstrated that C-Flex has comparable resolution of respiratory indices and adherence. Furthermore, C-Flex users reported greater mask comfort.</description><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Continuous positive airway pressure</subject><subject>Continuous Positive Airway Pressure - methods</subject><subject>Dentistry</subject><subject>Disorders of Excessive Somnolence - diagnosis</subject><subject>Disorders of Excessive Somnolence - etiology</subject><subject>Disorders of higher nervous function. Focal brain diseases. Central vestibular syndrome and deafness. Brain stem syndromes</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Humans</subject><subject>Hypoventilation</subject><subject>Internal Medicine</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</subject><subject>Nervous system (semeiology, syndromes)</subject><subject>Neurology</subject><subject>Original Article</subject><subject>Otorhinolaryngology</subject><subject>Patient Compliance</subject><subject>Pediatrics</subject><subject>Pneumology/Respiratory System</subject><subject>Polysomnography</subject><subject>Pressure</subject><subject>Prospective Studies</subject><subject>Single-Blind Method</subject><subject>Sleep Apnea, Obstructive - complications</subject><subject>Sleep Apnea, Obstructive - diagnosis</subject><subject>Sleep Apnea, Obstructive - therapy</subject><subject>Sleep. 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Randall</au><au>Strobel, Richard J.</au><au>Rosenthal, Leon</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Longitudinal comparison study of pressure relief (C-Flex™) vs. CPAP in OSA patients</atitle><jtitle>Sleep &amp; breathing</jtitle><stitle>Sleep Breath</stitle><addtitle>Sleep Breath</addtitle><date>2009-02-01</date><risdate>2009</risdate><volume>13</volume><issue>1</issue><spage>73</spage><epage>77</epage><pages>73-77</pages><issn>1520-9512</issn><eissn>1522-1709</eissn><abstract>Background Continuous positive airway pressure (CPAP) devices with the option of flexible pressure delivery (e.g., C-Flex) are thought to provide an improved degree of comfort and result in better therapeutic adherence while maintaining standard CPAP efficacy. The purpose of this study was to compare adherence and subjective measures of comfort between C-Flex and CPAP treatment. Methods The study was an international, multisite, single-blinded study with participants randomized to either C-Flex or CPAP. Participants completed subjective measures of sleepiness and comfort at baseline, and at 30-, 90-, and 180-day follow-ups. Additionally, compliance data were downloaded from the device at each follow-up. Repeated measures analysis of variance was used to assess the effects of treatment. Results There were 138 men and 46 women (average age of 48 ± 9.2, average Epworth Sleepiness Scale score of 14.9 ± 3.6, and average diagnostic apnea/hypopnea index (AHI) of 51.9 ± 27.7). C-Flex and CPAP groups were comparable on baseline measures, achieved comparable AHI on titration, and had comparable PAP pressure requirements. C-Flex users had comparable average hours of use per night and total nights of use across the study, but had a trend ( p &lt; .07) toward achieving greater total hours of utilization. While both groups had comparable decreases in sleepiness, C-Flex users reported on visual analog scales greater comfort (64.3 vs. 57.4; p = .01). Conclusions The results of this study demonstrated that C-Flex has comparable resolution of respiratory indices and adherence. Furthermore, C-Flex users reported greater mask comfort.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer-Verlag</pub><pmid>18551327</pmid><doi>10.1007/s11325-008-0199-1</doi><tpages>5</tpages></addata></record>
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subjects Adult
Aged
Biological and medical sciences
Continuous positive airway pressure
Continuous Positive Airway Pressure - methods
Dentistry
Disorders of Excessive Somnolence - diagnosis
Disorders of Excessive Somnolence - etiology
Disorders of higher nervous function. Focal brain diseases. Central vestibular syndrome and deafness. Brain stem syndromes
Female
Follow-Up Studies
Fundamental and applied biological sciences. Psychology
Humans
Hypoventilation
Internal Medicine
Male
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis
Nervous system (semeiology, syndromes)
Neurology
Original Article
Otorhinolaryngology
Patient Compliance
Pediatrics
Pneumology/Respiratory System
Polysomnography
Pressure
Prospective Studies
Single-Blind Method
Sleep Apnea, Obstructive - complications
Sleep Apnea, Obstructive - diagnosis
Sleep Apnea, Obstructive - therapy
Sleep. Vigilance
Surveys and Questionnaires
Vertebrates: nervous system and sense organs
title Longitudinal comparison study of pressure relief (C-Flex™) vs. CPAP in OSA patients
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