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NCT Number: NCT06678880

Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction

**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.

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Key information

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego Hillcrest Medical Center

San Diego, California, 92103, United States

Location status: Recruiting

Location contact

Barbara L Parry, M.D.

CONTACT

[email protected]

(619) 980-1942

Barbara L Parry, M.D.

PRINCIPAL_INVESTIGATOR

David H Sommerfeld, Ph.D.

CONTACT

[email protected]

(858) 472-9397

About this study

Our bodies naturally follow a 24-hour internal clock that helps regulate sleep, hormones, mood, and energy. During menopause, hormonal changes can disrupt the timing of this internal clock, which may contribute to mood changes, sleep problems, and low energy.

Participants will be asked to change their sleep timing for one night and use bright light at specific times of day for two weeks. In previous studies, some women experienced improvements in mood within days to weeks. SALI does not use medication and has few side effects.

Participants must live in San Diego County. Interested individuals will first complete a screening process to help determine whether this study is a good match for them and whether participation would be appropriate and safe. The screening includes questionnaires and interviews about health, mood, sleep, and mental health history. Not everyone who is screened will qualify to participate.

Study participation is approximately 4 ½ months, and includes:

  • 4 weeks of wearing an activity/light wrist sensor
  • 2 overnight urine collections to measure melatonin, the best measure of human circadian rhythms, and a hormone that helps regulate the timing of sleep
  • 1 night where the timing and duration of your sleep will be adjusted
  • 2 weeks of daily light box usage (30 minutes per day at a specified time) and daily surveys to track mood & side effects
  • Regularly scheduled Zoom interviews & online surveys to monitor your mood & sleep before and after SALI

All study activities can be done from the comfort of your home. Researchers hope this work will lead to new ways to improve mood and sleep during menopause and help identify treatments that can be tailored to each person's biological rhythms.

This is a research study, not a clinical treatment. Participation is confidential and voluntary. Participants may or may not benefit directly from participating. To receive full compensation, participants are required to complete study tasks on scheduled days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Urinary 6-sulfatoxymelatonin (6-SMT)

    Time frame: Urine is collected at baseline and after completing two-week intervention.

    Collected to measure melatonin, a hormone that helps regulate your sleep and body clocks.

  2. Structured Interview Guide for the Hamilton Rating Depression Scale with Atypical Depression Supplement (SIGH-ADS)

    Time frame: Completed at baseline and after completing two-week intervention.

    A clinician-conducted interview that asks about symptoms of depression, including mood, sleep, appetite, energy, and other emotional and physical symptoms.

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: Completed at baseline and after completing two-week intervention.

    A brief questionnaire that asks about common symptoms of depression, such as mood, sleep, energy, appetite, and concentration.

  4. Sleep Quality Rating (SQR)

    Time frame: Completed at baseline and after completing two-week intervention.

    A brief questionnaire to rate how well you have been sleeping and whether you have experienced any sleep-related problems.

Study contacts

Contact information is provided by the study sponsor or research team.

David Sommerfeld, Ph.D.

CONTACT

[email protected]

(407) 966-7703 ext. 243609

Jennifer A Perrott, MSW

CONTACT

[email protected]

(407) 619-9441

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Chronobiological Basis of Depression During the Menopause Transition

Acronym: SALI

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Nov 7, 2024
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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