The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial
Sponsor study identifier
interventional
44
1 country
1
Study Start
February 15, 2019
Actual (reported)Primary Completion
November 5, 2021
Actual (reported)Study Completion
November 5, 2021
Actual (reported)This study will test whether measuring the circadian clock during treatment of delayed sleep-wake phase disorder results in greater improvements in sleep compared to estimating the circadian clock.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 5, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2018
Actual (reported)October 23, 2018
Actual (reported)February 15, 2019
Actual (reported)November 5, 2021
Actual (reported)November 5, 2021
Actual (reported)November 25, 2022
Actual (reported)Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time and change in time of DLMO is measured in hours. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later onset of melatonin and negative scores indicate a shift towards an earlier onset of melatonin.
After 4 weeks of melatonin therapy
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks
After 4 weeks of melatonin therapy
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks
After 4 weeks of melatonin therapy
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks
After 4 weeks of melatonin therapy
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks
After 4 weeks of melatonin therapy
Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks
After 4 weeks of melatonin therapy
Four weeks (28 days) of nightly melatonin 0.5 mg fast dissolve tablets timed to be administered 3 hours before estimated dim light melatonin onset.
Four weeks (28 days) of nightly melatonin 0.5 mg fast dissolve tablets timed to be administered 3 hours before measured dim light melatonin onset.
Test to determine the time of melatonin onset in saliva under dim light conditions
University of Michigan
Ann Arbor, Michigan, 48109, United States
Swanson LM, de Sibour T, DuBuc K, Conroy DA, Raglan GB, Lorang K, Zollars J, Hershner S, Arnedt JT, Burgess HJ. 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 Jul 1;20(7):1131-1140. doi: 10.5664/jcsm.11076.
Leslie Swanson, Ph.D.
University of Michigan
44 participants (actual enrollment reported by the registry).
First Submitted
October 19, 2018
First Posted
October 23, 2018
Study Start
February 15, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 5, 2021
Actual (reported)Study Completion
November 5, 2021
Actual (reported)Last Updated
November 25, 2022
Results First Posted
November 25, 2022
Record last verified: 2022-10
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Source: ClinicalTrials.gov.
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