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
45 Years - 75 Years
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

\*\*Participants must live in San Diego County\*\* The purpose of this study is to learn more about an experimental Sleep \& Light Intervention (SALI) for menopausal mood changes or depression. Researchers want to find out whether adjusting the body's internal clock-which helps regulate sleep, hormones, mood, and energy- can improve symptoms such as depression, poor sleep, and low energy during menopause.

Key Dates

First listed
Nov 7, 2024
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: Group 1
    Participants assigned to the experimental condition.
  • Active Comparator: Group 2
    Participants assigned to the active comparator condition.

Primary Outcome Measure

Urinary 6-sulfatoxymelatonin (6-SMT) [ Time Frame: Urine is collected at 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)

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University of California San Diego Hillcrest Medical Center· San Diego, CA

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