- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03715465
The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Melatonin tablet
|
Experimental: 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.
|
Melatonin tablet
Test to determine the time of melatonin onset in saliva under dim light conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Change in total sleep time is measured in hours.
The change score is calculated by subtracting total sleep time at 4 weeks from total sleep time at baseline.
Thus, positive scores indicate an increase in total sleep time, whereas negative scores indicate a decrease in total sleep time.
|
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
Time Frame: After 4 weeks of melatonin therapy
|
Sleep onset time is measured in clock time and reflects time of falling asleep.
The change score is calculated as time at 4 weeks minus baseline time.
Thus, positive scores indicate a shift towards a later fall asleep time and negative scores indicate a shift towards an earlier fall asleep time.
|
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
Time Frame: After 4 weeks of melatonin therapy
|
Sleep offset time is measured in clock time and reflects time of waking for the day.
The change score is calculated as time at 4 weeks minus baseline time.
Thus, positive scores indicate a shift towards a later wake time and negative scores indicate a shift towards an earlier wake time.
|
After 4 weeks of melatonin therapy
|
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Length of time to sleep onset latency in minutes (reflects time to fall asleep).
The change score is calculated as time at 4 weeks minus baseline time.
Thus, a negative scores indicate a reduction in time to fall asleep, whereas positive scores indicate an increase in time to fall asleep.
|
After 4 weeks of melatonin therapy
|
Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Self-report of daytime sleepiness.
Scores range from 0 to 24.
Scores of 10 or higher indicate excessive daytime sleepiness.
The change score is calculated as score at 4 weeks minus baseline score.Thus, positive scores indicate an increase in sleepiness, whereas negative scores indicate a reduction in sleepiness.
|
After 4 weeks of melatonin therapy
|
Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Self-report of daytime fatigue.
Scores range from 20-100; higher scores indicate more fatigue.
The change score is calculated as score at 4 weeks minus baseline score.
Thus, positive scores indicate an increase in fatigue, whereas negative scores indicate a reduction in fatigue.
|
After 4 weeks of melatonin therapy
|
Change From Baseline Score on Sheehan Disability Scale at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Self-report of functional impairment in works/school, social, and family life. Scores range from 0-30; higher scores indicate more impairment. The change score is calculated as time at 4 weeks minus baseline time Thus, positive scores indicate increased impairment, whereas negative scores indicate a reduction in impairment. |
After 4 weeks of melatonin therapy
|
Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Self-report of depression symptoms.
Scores range from 0-27; higher scores indicate more severe depression.
The change score is calculated as score at 4 weeks minus baseline score.
Thus, positive scores indicate an increase in depression, whereas negative scores indicate a reduction in depression.
|
After 4 weeks of melatonin therapy
|
Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Self-report of generalized anxiety symptoms.
Scores range from 0-21; higher scores indicate more severe anxiety.
The change score is calculated as score at 4 weeks minus baseline score.
Thus, positive scores indicate an increase in anxiety, whereas negative scores indicate a reduction in anxiety.
|
After 4 weeks of melatonin therapy
|
Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Self-report of sleep quality.
Seven subscale scores are summed to obtain a global score.
Global scores range from 0 to 21; scores of 5 or higher indicate poor sleep quality.
The change score is calculated as score at 4 weeks minus baseline score.
Thus, positive scores indicate a worsening of sleep quality, whereas negative scores indicate an improvement in sleep quality.
|
After 4 weeks of melatonin therapy
|
Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Self-report of chronotype.
Scores range from 16-86.
Lower scores indicate more eveningness.The change score is calculated as score at 4 weeks minus baseline score.
Thus, positive scores indicate a shift towards more morningness, whereas negative scores indicate a shift towards more eveningness.
|
After 4 weeks of melatonin therapy
|
Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Self-report of sleep disturbances.
Scores range from 8-40.
Higher scores indicate greater sleep disturbance.
The change score is calculated as score at 4 weeks minus baseline score.
Thus, positive scores indicate a worsening of sleep disturbance, whereas negative scores indicate an improvement in sleep disturbance.
|
After 4 weeks of melatonin therapy
|
Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks
Time Frame: After 4 weeks of melatonin therapy
|
Self-report of impairment related to sleep. Scores range from 8-40. Higher scores indicate greater impairment due to sleep. The change score is calculated as score at 4 weeks minus baseline score. Thus, positive scores indicate an increase in impairment due to sleep, whereas negative scores indicate a reduction in impairment due to sleep. |
After 4 weeks of melatonin therapy
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leslie Swanson, Ph.D., University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Dyssomnias
- Sleep Wake Disorders
- Occupational Diseases
- Chronobiology Disorders
- Sleep Disorders, Circadian Rhythm
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Protective Agents
- Antioxidants
- Melatonin
Other Study ID Numbers
- HUM00145052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Delayed Sleep Phase Syndrome
-
Brigham and Women's HospitalCharite University, Berlin, Germany; Stanford UniversityRecruitingSleep Disorders, Intrinsic | Sleep Wake Disorders | Sleep Disorders, Circadian Rhythm | Advanced Sleep Phase Syndrome (ASPS) | Delayed Sleep Phase Syndrome | Shift-Work Sleep Disorder | Delayed Sleep Phase | Non-24 Hour Sleep-Wake Disorder | Advanced Sleep Phase Syndrome | Advanced Sleep Phase | Irregular... and other conditionsUnited States
-
University of PittsburghNational Institute on Drug Abuse (NIDA)Active, not recruiting
-
University of California, San FranciscoCompletedInsomnia | Delayed Sleep PhaseUnited States
-
Brigham and Women's HospitalActive, not recruitingSleep Disorders, Intrinsic | Sleep Disorders, Circadian Rhythm | Advanced Sleep Phase Syndrome (ASPS) | Delayed Sleep Phase Syndrome | Shift-Work Sleep Disorder | Delayed Sleep Phase | Non-24 Hour Sleep-Wake Disorder | Advanced Sleep Phase Syndrome | Advanced Sleep Phase | Irregular Sleep-Wake Syndrome | Shift...United States
-
Rush University Medical CenterNational Center for Complementary and Integrative Health (NCCIH)Completed
-
Stanford UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingDelayed Sleep Phase DisorderUnited States
-
University of California, San FranciscoRecruiting
-
Brigham and Women's HospitalStanford UniversityRecruitingSleep Wake Disorders | Sleep Disorder | Sleep Disorders, Circadian Rhythm | Circadian Rhythm Disorders | Circadian Rhythm Sleep Disorder | Advanced Sleep Phase Syndrome (ASPS) | Delayed Sleep Phase SyndromeUnited States
-
University of BergenCompletedDelayed Sleep Phase SyndromeNorway
-
Sheba Medical CenterUnknownDelayed Sleep Phase SyndromeIsrael
Clinical Trials on Melatonin 0.5 MG
-
Northwell HealthColumbia University; National Library of Medicine (NLM)Completed
-
Scripps HealthUniversity of California, San DiegoTerminated
-
Andrew J. Armstrong, MDCompletedProstate CancerUnited States
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesChina
-
Atox Bio LtdTerminatedAcute Kidney Injury | Peritonitis | Necrotizing Soft Tissue InfectionUnited States, France
-
Hoffmann-La RocheCompletedFragile X SyndromeFrance, Spain, United States, Peru, Canada, United Kingdom, Chile, Argentina, Mexico, Sweden
-
Khon Kaen UniversityUnknownPharmacokinetics of MelatoninThailand
-
AsclepiX Therapeutics, Inc.TerminatedDiabetic Macular Edema (DME)United States
-
Providence Health & ServicesCompletedRelapsing Remitting Multiple SclerosisUnited States
-
AsclepiX Therapeutics, Inc.TerminatedNeovascular Age-Related Macular Degeneration (nAMD)United States