Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.
Medical School, Medical College of Wisconsin, Milwaukee, Wisconsin.
J Clin Sleep Med. 2024 Jul 1;20(7):1131-1140. doi: 10.5664/jcsm.11076.
The purpose of the present study was to preliminarily evaluate whether knowing the dim light melatonin onset (DLMO) time is advantageous when treating delayed sleep-wake phase disorder with low-dose melatonin treatment plus behavioral interventions (ie, evening dim light and time in bed scheduling).
In this randomized, controlled, double-blind trial, 40 adults with delayed sleep-wake phase disorder were randomly assigned to 4 weeks of 0.5 mg timed to be administered either 3 hours before the DLMO (measured DLMO group, n = 20) or 5 hours before sleep-onset time per actigraphy (estimated DLMO group, n = 20), in conjunction with behavioral interventions. The primary outcome was change in the DLMO (measured in-home). Secondary outcomes included sleep parameters per diary and actigraphy (sleep-onset and -offset times and total sleep time), Morningness-Eveningness Questionnaire, Multidimensional Fatigue Inventory, PROMIS-Sleep Disturbance, PROMIS-Sleep Related Impairment, and Pittsburgh Sleep Quality Index. Mixed-effects models tested for group differences in these outcome.
After applying the Bonferroni correction for multiple comparisons (significant value set at < .004), there were significant main effects for visit on all outcomes except for the Pittsburgh Sleep Quality Index and total sleep time per wrist actigraphy and diary. There were no group-by-visit interactions for any of the outcomes ( > .004).
Scheduled low-dose melatonin plus behavioral interventions may improve many circadian and sleep parameters regardless of whether melatonin administration is scheduled based on estimated or measured DLMO. A larger-scale trial is needed to confirm these preliminary findings.
Registry: ClinicalTrials.gov; Name: The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder; URL: https://clinicaltrials.gov/study/NCT03715465; Identifier: NCT03715465.
Swanson LM, de Sibour T, DuBuc K, et al. Low-dose exogenous melatonin plus evening dim light and time in bed scheduling advances circadian phase irrespective of measured or estimated dim light melatonin onset time: preliminary findings. . 2024;20(7):1131-1140.
本研究旨在初步评估在使用低剂量褪黑素治疗联合行为干预（即傍晚暗光和床上时间安排）治疗睡眠时相后延障碍时，了解褪黑素分泌初始时间（DLMO）是否有益。
在这项随机、对照、双盲试验中，40 名睡眠时相后延障碍成人被随机分配至 4 周的 0.5mg 褪黑素治疗，褪黑素给药时间分别为根据多导睡眠图（实际 DLMO 组，n=20）或活动记录仪（估计 DLMO 组，n=20）测量的 DLMO 前 3 小时或前 5 小时，同时进行行为干预。主要结局为在家中测量的 DLMO 变化。次要结局包括日记和活动记录仪记录的睡眠参数（入睡和觉醒时间以及总睡眠时间）、主观时型问卷、多维疲劳量表、PROMIS-睡眠障碍、PROMIS-睡眠相关损害、匹兹堡睡眠质量指数。混合效应模型检验了这些结局的组间差异。
在对多次比较进行 Bonferroni 校正（显著 值设定为<.004）后，除匹兹堡睡眠质量指数和腕部活动记录仪和日记记录的总睡眠时间外，所有结局在就诊时均有显著的主效应。任何结局均无组间就诊时交互作用（>.004）。
基于估计或测量的 DLMO 安排褪黑素给药，低剂量褪黑素联合行为干预可能会改善许多昼夜节律和睡眠参数。需要更大规模的试验来证实这些初步发现。
注册机构：ClinicalTrials.gov；名称：测量生物钟在治疗睡眠时相后延障碍中的临床效用；网址：https://clinicaltrials.gov/study/NCT03715465；标识符：NCT03715465。
Swanson LM, de Sibour T, DuBuc K, et al. Low-dose exogenous melatonin plus evening dim light and time in bed scheduling advances circadian phase irrespective of measured or estimated dim light melatonin onset time: preliminary findings.. 2024;20(7):1131-1140.
