Skip to main content
OpenTrials
Completed

NCT Number: NCT03715465

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delayed Sleep Phase Syndrome Chronobiology Disorders Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Sleep Disorders, Circadian Rhythm Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 0.5 MG

Drug

Melatonin tablet

Dim Light Melatonin Onset (salivary)

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Academy of Sleep Medicine

Registry information

Official study title

The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2018
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.