Phase 3 N=40 Randomized Double-blind Treatment

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

Delayed Sleep Phase Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03715465 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcome: Primary: Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks — -1.23; -1.58 Hours — p=0.510

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Melatonin 0.5 MG (Drug); Dim Light Melatonin Onset (salivary) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 4 Weeks	-1.23; -1.58	0.510
SECONDARY Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Total Sleep Time at 4 Weeks	0.41; 0.65; 0.63; 0.66	0.411
SECONDARY Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Onset Time at 4 Weeks	-1.73; -1.84; -1.58; -1.63	0.787
SECONDARY Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Diary Parameters - Sleep Offset Time at 4 Weeks	-1.61; -1.96; -1.15; -1.45	0.270
SECONDARY Change From Baseline Score on Wrist Actigraphy and Self-Report Diary Sleep Onset Latency at 4 Weeks	-14.35; -10.21; -9.75; -0.53	0.635
SECONDARY Change From Baseline Score on Epworth Sleepiness Scale at 4 Weeks	-1.61; -0.78	0.456
SECONDARY Change From Baseline Score on Multidimensional Fatigue Inventory at 4 Weeks	-3.78; -6.50	0.402
SECONDARY Change From Baseline Score on Sheehan Disability Scale at 4 Weeks	-0.33; -5.85	0.047 sig
SECONDARY Change From Baseline Score on Patient Health Questionnaire-9 at 4 Weeks	0.28; -0.39	0.525
SECONDARY Change From Baseline Score on Generalized Anxiety Disorder-7 Scale at 4 Weeks	1.11; -0.50	0.106
SECONDARY Change From Baseline Score on the Pittsburgh Sleep Quality Index at 4 Weeks	1.61; -0.59	0.059
SECONDARY Change From Baseline Score on the Morningness Eveningness Questionnaire at 4 Weeks	4.89; 12.17	0.007 sig
SECONDARY Change From Baseline Score on the PROMIS-Sleep Disturbance Scale at 4 Weeks	-3.56; -5.94	0.246
SECONDARY Change From Baseline Score on the PROMIS-Sleep Related Impairment Scale at 4 Weeks	-3.94; -6.11	0.333

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03715465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.