Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction (NCT06678880) | Clinical Trial Compass
RecruitingNot Applicable
Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction
United States120 participantsStarted 2025-03-11
Plain-language summary
\*\*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.
Who can participate
Age range
45 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women aged 45-75 years old
* Experiencing significant down, sad or hopeless feelings that are affecting their daily life
* These mood changes started or got worse during the menopause transition
* Irregular or no menstrual cycle for at least 6 months
* Non-smoking
* Located in San Diego County
Exclusion Criteria:
* Untreated sleep apnea
* Migraine headaches that are triggered or worsened by bright light
* Currently suicidal or psychotic
* History of bipolar disorder
* A medical condition or job where fatigue or changes in sleep schedule could be unsafe
* Planning to start, stop, or change medications in the next 4 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is looking at sleep and light exposure as a way to treat depression during the menopausal transition — could my doctor explain whether my specific symptoms, like my sleep problems and mood changes, are the kind this study is designed to address?
2The trial is measuring melatonin levels through urine samples alongside depression and sleep rating scales — can my doctor walk me through what that testing schedule would actually look like day-to-day, and whether the demands of regular sampling and assessments would fit my life right now?
3Since this study is listed as Phase NA, which often means it's behavioral or non-drug research rather than a medication trial, can my doctor help me understand what the actual intervention involves — like whether it's light therapy, sleep coaching, or something else — and how it compares to standard treatments for menopausal depression I could pursue right now?
4The trial uses both a clinician-administered interview scale and a self-reported questionnaire to measure depression — does my doctor think my current depression severity is well-suited to this kind of study, or would a more established treatment be a better first step for me?
5Given that this research is actively recruiting, can my doctor help me understand what participation would mean for my existing care — for example, whether I'd need to pause or adjust any current medications or hormone therapy I'm already taking?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Urinary 6-sulfatoxymelatonin (6-SMT)
Timeframe: Urine is collected at baseline and after completing two-week intervention.
2
Structured Interview Guide for the Hamilton Rating Depression Scale with Atypical Depression Supplement (SIGH-ADS)
Timeframe: Completed at baseline and after completing two-week intervention.
3
Patient Health Questionnaire (PHQ-9)
Timeframe: Completed at baseline and after completing two-week intervention.
4
Sleep Quality Rating (SQR)
Timeframe: Completed at baseline and after completing two-week intervention.