search
Back to results

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

Primary Purpose

Delayed Sleep Phase Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Melatonin 0.5 MG
Dim Light Melatonin Onset (salivary)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Sleep Phase Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Estimated DLMO

Measured DLMO

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks
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 Outcome Measures

Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks
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.
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks
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.
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks
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.
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks
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.
Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks
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.
Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks
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.
Change From Baseline Score on Sheehan Disability Scale at 4 Weeks
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.
Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks
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.
Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks
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.
Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks
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.
Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks
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.
Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks
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.
Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks
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.

Full Information

First Posted
October 19, 2018
Last Updated
October 31, 2022
Sponsor
University of Michigan
Collaborators
American Academy of Sleep Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03715465
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
American Academy of Sleep Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Sleep Phase Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estimated DLMO
Arm Type
Active Comparator
Arm 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.
Arm Title
Measured DLMO
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Melatonin 0.5 MG
Intervention Description
Melatonin tablet
Intervention Type
Other
Intervention Name(s)
Dim Light Melatonin Onset (salivary)
Intervention Description
Test to determine the time of melatonin onset in saliva under dim light conditions
Primary Outcome Measure Information:
Title
Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Secondary Outcome Measure Information:
Title
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on Sheehan Disability Scale at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy
Title
Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks
Description
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.
Time Frame
After 4 weeks of melatonin therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Swanson, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs