Status:
COMPLETED
Validation of Circadian Biomarkers in Patients With Sleep Disorders
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Stanford University
Conditions:
Sleep Disorders, Circadian Rhythm
Circadian Rhythm Disorders
Eligibility:
All Genders
18-65 years
Brief Summary
Current methods for assessing circadian timing require sampling over hours (or even up to a day) while the patient is in controlled conditions. The investigators aim to develop a method that can estim...
Detailed Description
Adults who meet ICSD-3 criteria for Advanced Sleep Wake Phase Disorder or Delayed Sleep Wake Phase Disorder will be studied at Brigham and Women's Hospital and Stanford University. The outpatient pro...
Eligibility Criteria
Inclusion
- ICSD3 diagnosis of Advanced Sleep-Wake Phase Disorder or Delayed Sleep-Wake Phase Disorder
- otherwise healthy
Exclusion
- history of drug or alcohol dependency
- a sleep disorder other than a circadian rhythm sleep disorder
- use of medications that interfere with melatonin production (e.g., beta blockers) within the past month
- night shift work (for ASWPD patients) or early morning starts (for DSWPD patients) in the prior 3 years
- recent (within 3 months) travel to a place 2 time zones or greater away from home
- acute or uncontrolled medical conditions
- major visual deficit
- active or uncontrolled psychological or psychiatric disorder
- use of exogenous melatonin or melatonin agonists within the past month
Key Trial Info
Start Date :
November 2 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04690504
Start Date
November 2 2021
End Date
July 1 2024
Last Update
August 6 2024
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115