Aloia Mark S, Stanchina Michael, Arnedt J Todd, Malhotra Atul, Millman Richard P
Department of Psychiatry and Human Behavior, Brown Medical School, Providence RI, USA.
Chest. 2005 Jun;127(6):2085-93. doi: 10.1378/chest.127.6.2085.
To compare adherence and clinical outcomes between flexible positive airway pressure (PAP) [C-Flex; Respironics; Murraysville, PA] and standard PAP therapy (ie, continuous positive airway pressure [CPAP]).
A controlled clinical trial of CPAP therapy vs therapy using the C-Flex device in participants with moderate-to-severe obstructive sleep apnea. Participants were recruited from and followed up through an academic sleep disorders center.
Eighty-nine participants were recruited into the study after they had undergone complete in-laboratory polysomnography and before initiating therapy. Participants received either therapy with CPAP (n = 41) or with the C-Flex device (n = 48), depending on the available treatment at the time of recruitment, with those recruited earlier receiving CPAP therapy and those recruited later receiving therapy with the C-Flex device. Follow-up assessments were conducted at 3 months.
The groups were similar demographically. The mean (+/- SD) treatment adherence over the 3-month follow-up period was higher in the C-Flex group compared to the CPAP group (weeks 2 to 4, 4.2 +/- 2.4 vs 3.5 +/- 2.8, respectively; weeks 9 to 12, 4.8 +/- 2.4 vs 3.1 +/- 2.8, respectively). Clinical outcomes and attitudes toward treatment (self-efficacy) were also measured. Change in subjective sleepiness and functional outcomes associated with sleep did not improve more in one group over the other. Self-efficacy showed a trend toward being higher at the follow-up in those patients who had been treated with the C-Flex device compared to CPAP treatment.
Therapy with the C-Flex device may improve overall adherence over 3 months compared to standard therapy with CPAP. Clinical outcomes do not improve consistently, but C-Flex users may be more confident about their ability to adhere to treatment. Randomized clinical trials are needed to replicate these findings.
比较灵活气道正压通气(PAP)[C-Flex;瑞思迈公司;宾夕法尼亚州默里斯维尔]与标准PAP治疗(即持续气道正压通气[CPAP])的依从性和临床结局。
一项针对中度至重度阻塞性睡眠呼吸暂停患者的CPAP治疗与使用C-Flex设备治疗的对照临床试验。参与者从一个学术性睡眠障碍中心招募并进行随访。
89名参与者在完成实验室多导睡眠监测后且开始治疗前被纳入研究。参与者根据招募时可获得的治疗方式接受CPAP治疗(n = 41)或C-Flex设备治疗(n = 48),较早招募的参与者接受CPAP治疗,较晚招募的参与者接受C-Flex设备治疗。在3个月时进行随访评估。
两组在人口统计学方面相似。在3个月的随访期内,C-Flex组的平均(±标准差)治疗依从性高于CPAP组(第2至4周,分别为4.2±2.4和3.5±2.8;第9至12周,分别为4.8±2.4和3.1±2.8)。还测量了临床结局和对治疗的态度(自我效能感)。与睡眠相关的主观嗜睡和功能结局的改善在两组之间没有更明显的差异。与CPAP治疗相比,接受C-Flex设备治疗的患者在随访时自我效能感有升高趋势。
与CPAP标准治疗相比,使用C-Flex设备治疗可能在3个月内提高总体依从性。临床结局并非持续改善,但使用C-Flex设备的患者可能对坚持治疗的能力更有信心。需要进行随机临床试验来重复这些发现。