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

University of Michigan

Status and phase: Completed; Phase 3

Conditions: Delayed Sleep Phase Syndrome

Treatments: Drug: Melatonin 0.5 MG; Other: Dim Light Melatonin Onset (salivary)

Study type: Interventional

Funder types: Other

Identifiers

NCT03715465

HUM00145052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Estimated DLMO

Active Comparator group

Description:

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.

Treatment:

Drug: Melatonin 0.5 MG

Measured DLMO

Experimental group

Description:

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.

Treatment:

Other: Dim Light Melatonin Onset (salivary)

Drug: Melatonin 0.5 MG