Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction

NCT06678880 | Recruiting DMC

• 1 other identifier: MH134120
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Depression During the Menopausal Transition; Menopausal Depression

Keywords

Menopause; depression; sleep and light intervention; melatonin; circadian rhythm; Chronobiology

Outcome Measures

Primary Outcomes (4)

• Urinary 6-sulfatoxymelatonin (6-SMT)

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

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

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

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

  Completed at baseline and after completing two-week intervention.

• Patient Health Questionnaire (PHQ-9)

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

  Completed at baseline and after completing two-week intervention.

• Sleep Quality Rating (SQR)

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

  Completed at baseline and after completing two-week intervention.

Study Arms (2)

Group 1

EXPERIMENTAL

Participants assigned to the experimental condition.

Behavioral: Phase Advanced Intervention (PAI)

Group 2

ACTIVE COMPARATOR

Participants assigned to the active comparator condition.

Behavioral: Phase Delay Intervention (PDI)

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.

Group 1

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.

Group 2

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: As only biological women undergo menopause, only biological women will be eligible for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego Hillcrest Medical Center

San Diego, California, 92103, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Barbara Parry, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer A Perrott, MSW

CONTACT

(407) 619-9441; jperrott@health.ucsd.edu

David Sommerfeld, Ph.D.

CONTACT

(407) 966-7703; dsommerfeld@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 7, 2024
• Study Start: March 11, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: August 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)