Clinical trial NCT03715465: The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
Official title: The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Delayed Sleep Phase Syndrome
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
First posted: 2018-10-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
Secondary outcomes:
measure: Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on Sheehan Disability Scale at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
measure: Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks
timeFrame: After 4 weeks of melatonin therapy
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Leslie Swanson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: