Journal Article

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

Lorang, Kate, de Sibour, Trevor, Conroy, Deirdre A., Zollars, Jennifer, Arnedt, J. Todd, DuBuc, Kelley, Swanson, Leslie M., Raglan, Greta B., Burgess, Helen J., Hershner, Shelley

2024

Overview

Study Objectives: 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). Methods: 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. Results: After applying the Bonferroni correction for multiple comparisons (significant P 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 ( P > .004). Conclusions: 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. Clinical Trial Registration: 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. Citation: 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. J Clin Sleep Med . 2024;20(7):1131–1140.

• Publisher: Springer International Publishing,Springer Nature B.V,American Academy of Sleep Medicine
• Subject: Actigraphy - methods / Actigraphy - statistics & numerical data / Adult / Circadian rhythm / Circadian Rhythm - drug effects / Circadian Rhythm - physiology / Clinical outcomes / Clinical practice guidelines / Double-Blind Method / Drug dosages / Female / Humans / Insomnia / Light / Light therapy / Male / Medical records / Medicine / Melatonin / Melatonin - administration & dosage / Middle Aged / Patients / Post traumatic stress disorder / Schedules / Scheduling / Scientific Investigations / Sleep disorders / Sleep Disorders, Circadian Rhythm - drug therapy / Substance abuse treatment / Surveys and Questionnaires / Time Factors / Treatment Outcome