Biomarkers for Circadian Timing in Healthy Adults

Mass General Brigham

Status: Terminated

Conditions: Advanced Sleep Phase Syndrome; Shift-Work Sleep Disorder; Sleep Disorders, Intrinsic; Irregular Sleep-Wake Syndrome; Sleep Wake Disorders; Delayed Phase Sleep Syndrome; Advanced Sleep Phase Syndrome (ASPS); Advanced Sleep Phase; Non-24 Hour Sleep-Wake Disorder; Delayed Sleep Phase Syndrome; Delayed Sleep Phase; Sleep Disorders, Circadian Rhythm; Shift Work Type Circadian Rhythm Sleep Disorder

Treatments: Behavioral: constant routine; Behavioral: sleep-wake timing

Study type: Observational

Funder types: Other

Identifiers

NCT03956745

2019-P-001247

Details and patient eligibility

About

Study investigators want to learn more about the underlying biological clock and to see if the timing of that clock can be estimated from a single blood sample.

Full description

There is an urgent need for a practical way to assess circadian timing accurately in both general and sleep medicine. The study is designed to assess the levels of different biomarkers in the blood taken from frequent samples across three separate sleep-wake conditions - Conventional/Normal sleep-wake conditions (baseline), extended wake/acute sleep deprivation (constant routine), and during irregular sleep-wake conditions (inverted day). Participants will be asked to complete medical, psychological, and sleep-wake evaluations prior to the study. Upon completion of screening, if eligible, participants will stay 7 consecutive days and nights in the sleep research laboratory within the hospital.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults with conventional and regular sleep-wake timing
• Non-smokers
• Able to spend 7 consecutive days/nights in the laboratory
• Willing to abstain from use of caffeine, nicotine, and alcohol during pre-study and study periods

Exclusion criteria

• History of neurological or psychiatric disorder
• History of sleep disorder or regular use of sleep-promoting medication
• Current prescription, herbal, or over-the-counter medication use
• Traveling across 2 or more time zones within the past 3 months
• Donating blood within the past 8 weeks
• Worked night or rotating shiftwork within the past 3 years
• Hearing impairment
• Drug or Alcohol dependency
• Pregnant, intending to become pregnant, or recently pregnant (last 6 months)
• Breastfeeding within the past 6 months