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.
Study Goal
The researchers aimed to determine whether measuring dim light melatonin onset (DLMO) time improves the effectiveness of low-dose melatonin treatment combined with behavioral interventions (evening dim light and time in bed scheduling) for advancing circadian phase in adults with delayed sleep-wake phase disorder.
Results Summary
The study found that low-dose melatonin plus behavioral interventions improved circadian and sleep parameters, with no significant difference between groups using measured or estimated DLMO timing. However, the lack of group-by-visit interactions suggests that measuring DLMO may not provide additional benefits over estimation. The findings are preliminary and require larger-scale confirmation.
Population
40 adults with delayed sleep-wake phase disorder.
Effective Dosage
0.5 mg melatonin, timed 3 hours before measured DLMO or 5 hours before actigraphy-based sleep onset.
Duration
4 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
low-dose melatonin treatment plus behavioral interventions (ie, evening dim light and time in bed scheduling) | increase | many circadian and sleep parameters | adults with delayed sleep-wake phase disorder | - | may improve | #1 |
low-dose exogenous melatonin plus evening dim light and time in bed scheduling | increase | circadian phase | adults with delayed sleep-wake phase disorder | - | advances | #2 |
0.5 mg melatonin timed to be administered either 3 hours before the DLMO (measured DLMO group) or 5 hours before sleep-onset time per actigraphy (estimated DLMO group), in conjunction with behavioral interventions | no change | any of the outcomes | adults with delayed sleep-wake phase disorder | - | no group-by-visit interactions | #3 |
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.