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

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.

Conditions

Depression; Depression During the Menopausal Transition; Menopausal Depression

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Urine-based 6-sulfatoxymelatonin (6-SMT)

  Change in melatonin onset, offset, and acrophase.

  Baseline and after completing two-week intervention.

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

  Clinicians rate change in mood on a numerical scale where 0= little/no symptoms and a higher number indicates increased symptoms or impairment.

  Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.

• Patient Health Questionnaire (PHQ-9)

  PHQ-9 assesses mood. Participants rate items on a scale of 0 to 3, where 0 = Not at all; 1 = Several days; 2 = More than half the days; 3 = Nearly every day.

  Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.

• Sleep Quality Rating (SQR)

  Participants will rate their sleep quality as well as whether they feel rested and alert using a slider scale. For this scale, lower value indicates better scores while higher values indicate worse scores.

  Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.

• Objective Measures of Sleep

  Change in sleep timing and duration (objectively measured via continuously worn MotionWatch device)

  Continuous monitoring from one week prior to baseline through one week post intervention completion.

• Objective Measures of Physical Activity

  Change in physical activity (objectively measured via continuously worn MotionWatch device)

  Continuous monitoring from one week prior to baseline through one week post intervention completion.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants assigned to the experimental condition.

Behavioral: Phase Advanced Intervention (PAI)

Active Comparator Group

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.

Experimental Group

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.

Active Comparator Group

Eligibility Criteria

• Age: 18 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:

• 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)

You may not qualify if:

• 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

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: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)