Cheng Philip, Kalmbach David, Fellman-Couture Cynthia, Arnedt J Todd, Cuamatzi-Castelan Andrea, Drake Christopher L
Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.
Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan.
J Clin Sleep Med. 2020 Feb 15;16(2):193-198. doi: 10.5664/jcsm.8164. Epub 2020 Jan 13.
Sleep restriction therapy (SRT) has been shown to be comparably effective relative to cognitive behavioral therapy for insomnia (CBT-I), but with lower requirements for patient contact. As such, SRT appears to be a viable alternate treatment for those who cannot complete a full course of CBT-I. However, it is unclear whether SRT-a treatment solely focusing on restricting time in bed-increases risk for sleepiness comparably to CBT-I. The current study tested objective sleepiness as an outcome in a randomized controlled trial comparing SRT, CBT-I, and attention control in a sample of postmenopausal women in whom insomnia was diagnosed according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
Single-site, randomized controlled trial. A total of 150 postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition insomnia disorder were randomized to 3 treatment conditions: sleep education control (6 sessions); SRT (2 sessions with interim phone contact); and CBT-I (6 sessions). Blinded assessments were performed at pretreatment and posttreatment. Risk of excessive sleepiness was evaluated using a symmetry analysis of sleepiness measured through the Multiple Sleep Latency Test (MSLT).
The odds ratios (ORs) of being excessively sleepy versus nonsleepy were not different than 1.0 for both SRT (OR = 0.94, 95% confidence interval [0.13-6.96]) and CBT-I (OR = 0.62, 95% confidence interval [0.09-4.46]), indicating that the odds of becoming excessively sleepy following treatment was not different from the odds of being nonsleepy. This suggests that excessive sleepiness is not of unique concern following SRT relative to CBT-I or sleep education.
SRT appears to have a comparable risk profile for excessive sleepiness as CBT-I, and thus may be considered a safe alternative to CBT-I. Future research should characterize objective measures of excessive sleepiness immediately following sleep restriction.
Registry: ClinicalTrials.gov; Name: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295.
睡眠限制疗法（SRT）已被证明相对于失眠认知行为疗法（CBT-I）具有相当的疗效，但对患者接触的要求较低。因此，SRT似乎是那些无法完成完整疗程CBT-I的患者的一种可行替代治疗方法。然而，尚不清楚仅专注于限制卧床时间的SRT治疗是否会与CBT-I一样增加嗜睡风险。本研究在一项随机对照试验中，以客观嗜睡作为一项结果指标，比较了SRT、CBT-I和注意力控制，研究样本为根据《精神疾病诊断与统计手册》第五版标准诊断为失眠的绝经后女性。
单中心随机对照试验。共有150名绝经后女性（年龄56.44±5.64岁），她们患有《精神疾病诊断与统计手册》第五版中围绝经期或绝经后发作的失眠障碍，被随机分配到3种治疗组：睡眠教育对照组（6次治疗）；SRT组（2次治疗及期间电话联系）；CBT-I组（6次治疗）。在治疗前和治疗后进行盲法评估。使用通过多次睡眠潜伏期试验（MSLT）测量的嗜睡情况的对称性分析来评估过度嗜睡的风险。
SRT组（比值比[OR]=0.94，95%置信区间[0.13 - 6.96]）和CBT-I组（OR = 0.62，95%置信区间[0.09 - 4.46]）过度嗜睡与非嗜睡的比值比均不不同于1.0，这表明治疗后变得过度嗜睡的几率与非嗜睡的几率没有差异。这表明相对于CBT-I或睡眠教育，SRT治疗后过度嗜睡并非特别需要关注的问题。
SRT在过度嗜睡方面似乎与CBT-I具有相当的风险状况，因此可被视为CBT-I的一种安全替代方法。未来的研究应明确在睡眠限制后立即出现的过度嗜睡的客观测量指标。
注册机构：ClinicalTrials.gov；名称：绝经后失眠的行为治疗；睡眠和日间结果；标识符：NCT0193329
