Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction
Chronobiological Basis of Depression During the Menopause Transition
University of California, San Diego
120 participants
Mar 11, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Perimenopausal women with irregular menstrual cycles for at least 3 months
- Above age 18
- Experiencing at least moderate depression symptoms (i.e., score of at least 10 on PHQ-9)
Exclusion Criteria5
- Actively suicidal or psychotic
- History of bipolar disorder
- Staring new medications that would affect outcome measures (e.g., melatonin)
- Those in whom sleep restriction would be ill-advised (e.g., patients with epilepsy or those with occupations whose safety would be compromised).
- Women whose body mass index (BMI) exceeds the NIH criteria of \<18 or \> than 30
Interventions
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-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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06678880