The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder

NCT ID: NCT03715465

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2021-11-05

Brief Summary

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.

Detailed Description

The study is a randomized, controlled, parallel double-blind 4-week trial of 0.5 mgs of exogenous melatonin timed to either 3 h before actual dim light melatonin onset (DLMO) based on in-home measurement (M-DLMO, n = 25) or 3 h before DLMO estimated at 2 h before average sleep onset time based on actigraphy and sleep diary (E-DLMO, n = 25) in adult participants with delayed sleep-wake phase disorder. All participants will receive melatonin 0.5 mgs. Outcomes include change in DLMO, subjective and objective sleep parameters, and daytime symptoms.

As of January 7, 2020, the Insomnia Severity Index was removed from the IRB-approved protocol. No data were collected for this measure.

Conditions

Delayed Sleep Phase Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Estimated DLMO

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.

Group Type: ACTIVE_COMPARATOR

Melatonin 0.5 MG

Intervention Type: DRUG

Melatonin tablet

Measured DLMO

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.

Group Type: EXPERIMENTAL

Melatonin 0.5 MG

Intervention Type: DRUG

Melatonin tablet

Dim Light Melatonin Onset (salivary)

Intervention Type: OTHER

Test to determine the time of melatonin onset in saliva under dim light conditions

Interventions

Melatonin 0.5 MG

Melatonin tablet

Intervention Type: DRUG

Dim Light Melatonin Onset (salivary)

Test to determine the time of melatonin onset in saliva under dim light conditions

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Meet diagnostic criteria for delayed sleep wake phase disorder
• Female participants of childbearing potential must agree to use a reliable method of contraception from the screening visit until 4 weeks after the study has completed.

Exclusion Criteria

• Hypersensitivity to melatonin or any other component of the product
• Sleep disorder other than delayed sleep wake phase disorder
• Medical and psychiatric conditions that may influence sleep or be affected by melatonin
• Current use of medications which may have interactions with melatonin
• Pregnancy or breastfeeding
• Routine night shift work
• Past month travel or planned travel during the study across more than one time zone
• Use of melatonin in the past month
• Current use of medications that may interfere with the measurement of melatonin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Sleep Medicine

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Leslie Swanson

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leslie Swanson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38445651 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00145052

Identifier Type: -

Identifier Source: org_study_id