Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06678880
Status
Recruiting
Apply to this trial

Conditions

  • Depression
  • Depression During the Menopausal Transition
  • Menopausal Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phase Advanced Intervention (PAI) — BEHAVIORAL
    Phase-advanced restricted sleep (i.e., sleep 9pm-1am only) for 1 night, followed by morning bright white light for 30 min/day for 2 weeks.
  • Phase Delay Intervention (PDI) — BEHAVIORAL
    Phase-delayed restricted sleep (i.e., sleep 3am to 7am only) for 1 night, followed by evening bright white light for 30 min/day for 2 weeks.

Study Details

The goal of this clinical trial is to learn more about mood, sleep, and activity during menopause. The main question it aims to answer is: can mood and sleep dysfunction in menopause be improved by resetting misaligned circadian rhythm through one night of strategic sleep timing adjustment and two weeks of exposure to bright light at a certain time of day? Researchers will compare sleep timing (earlier vs. later) and bright white light exposure (morning or evening) to investigate the effect of melatonin levels on mood, sleep, and activity. Participants will 1) submit urine samples to measure melatonin levels, 2) be assigned to advance or delay their sleep for one night, 3) sit in front of a light box for 30 minutes per day (morning or evening) for 14 days, 4) complete questionnaires about their mood and sleep, and 5) wear a device that will measure their activity.

Key Dates

Start date
Mar 11, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    Participants assigned to the experimental condition.
  • Active Comparator: Active Comparator Group
    Participants assigned to the active comparator condition.

Primary Outcome Measure

Urine-based 6-sulfatoxymelatonin (6-SMT) [ Time Frame: Baseline and after completing two-week intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San Diego Hillcrest Medical CenterSan DiegoCalifornia92103
Barbara L Parry, M.D.
[email protected]
(619) 980-1942
David H Sommerfeld, Ph.D.
[email protected]
(858) 472-9397
Barbara L Parry, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California San Diego Hillcrest Medical Center· San Diego, CA

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