RecruitingNot ApplicableNCT06678880

Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction

Chronobiological Basis of Depression During the Menopause Transition


Sponsor

University of California, San Diego

Enrollment

120 participants

Start Date

Mar 11, 2025

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combined sleep and light therapy program for perimenopausal women experiencing depression linked to hormonal changes during the transition to menopause. The intervention uses structured light exposure and sleep behavior strategies to improve mood. **You may be eligible if...** - You are a woman going through perimenopause (irregular periods for at least 3 months) - You are 18 or older - You have at least moderate depression symptoms (PHQ-9 score of 10 or higher) **You may NOT be eligible if...** - You are actively suicidal or experiencing psychosis - You have bipolar disorder - You are already using certain medications or treatments that could interfere (e.g., hormone therapy or antidepressants started recently) - You have sleep disorders that require separate treatment (e.g., severe sleep apnea) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPhase Advanced Intervention (PAI)

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.

BEHAVIORALPhase Delay Intervention (PDI)

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)

University of California San Diego Hillcrest Medical Center

San Diego, California, United States

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NCT06678880


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