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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03715465
Collaborator
(none)
44
1
2
32.7
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 0.5 MG
  • Other: Dim Light Melatonin Onset (salivary)
Phase 3

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, as it was unnecessary to the goals of this trial.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial
Actual Study Start Date :
Feb 15, 2019
Actual Primary Completion Date :
Nov 5, 2021
Actual Study Completion Date :
Nov 5, 2021

Arms and Interventions

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.

Drug: Melatonin 0.5 MG
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.

Drug: Melatonin 0.5 MG
Melatonin tablet

Other: Dim Light Melatonin Onset (salivary)
Test to determine the time of melatonin onset in saliva under dim light conditions

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks [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, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin

Secondary Outcome Measures

  1. Change From Baseline Score on Sleep Diary Parameters at 4 Weeks [After 4 weeks of melatonin therapy]

    Total sleep time, initial sleep latency, sleep onset time, sleep offset time per self-report.

  2. Change From Baseline Score on Wrist Actigraphy Sleep Parameters at 4 Weeks [After 4 weeks of melatonin therapy]

    Total sleep time, initial sleep latency, sleep onset time, sleep offset time per wrist actigraphy.

  3. Change From Baseline Score on Epworth Sleepiness Scale at 4 weeks [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.

  4. Change From Baseline Score on Multidimensional Fatigue Inventory at 4 weeks [After 4 weeks of melatonin therapy]

    Self-report of daytime fatigue. Scores range from 20-100; higher scores indicate more fatigue.

  5. Change From Baseline Score on Sheehan Disability Scale at 4 weeks [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.

  6. Change From Baseline Score on Patient Health Questionnaire-9 at 4 weeks [After 4 weeks of melatonin therapy]

    Self-report of depression symptoms. Scores range from 0-27; higher scores indicate more severe depression.

  7. Change from Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 weeks [After 4 weeks of melatonin therapy]

    Self-report of generalized anxiety symptoms. Scores range from 0-21; higher scores indicate more severe anxiety.

  8. Change from Baseline Score on the Pittsburgh Sleep Quality Index at 4 weeks [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.

  9. Change from Baseline Score on the Morningness Eveningness Questionnaire at 4 weeks [After 4 weeks of melatonin therapy]

    Self-report of chronotype. Scores range from 16-86. Lower scores indicate more eveningness.

  10. Change from Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 weeks [After 4 weeks of melatonin therapy]

    Self-report of sleep disturbances. Scores range from 8-40. Higher scores indicate greater sleep disturbance.

  11. Change from Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 weeks [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: Leslie Swanson, Ph.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leslie Swanson, Clinical Associate Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT03715465
Other Study ID Numbers:
  • HUM00145052
First Posted:
Oct 23, 2018
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022