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

NCT03715465 | Completed Phase 3 Results FDA Drug

• 1 other identifier: HUM00145052
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Delayed Sleep Phase Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  After 4 weeks of melatonin therapy

Secondary Outcomes (13)

• Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks

  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

  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

  After 4 weeks of melatonin therapy

• Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks

  After 4 weeks of melatonin therapy

• Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks

  After 4 weeks of melatonin therapy

Study Arms (2)

Estimated DLMO

ACTIVE COMPARATOR

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

Measured DLMO

EXPERIMENTAL

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; Other: Dim Light Melatonin Onset (salivary)

Interventions

Melatonin 0.5 MG DRUG

Melatonin tablet

Estimated DLMO; Measured DLMO

Dim Light Melatonin Onset (salivary) OTHER

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

Measured DLMO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Swanson LM, de Sibour T, DuBuc K, Conroy DA, Raglan GB, Lorang K, Zollars J, Hershner S, Arnedt JT, Burgess HJ. Low-dose exogenous melatonin plus evening dim light and time in bed scheduling advances circadian phase irrespective of measured or estimated dim light melatonin onset time: preliminary findings. J Clin Sleep Med. 2024 Jul 1;20(7):1131-1140. doi: 10.5664/jcsm.11076.

  PMID: 38445651 DERIVED

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Leslie Swanson
• Organization: University of Michigan

lmswan@med.umich.edu

734-764-2242

Study Officials

• Leslie Swanson, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: February 15, 2019
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: November 25, 2022
• Results First Posted: November 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)