Recruiting

Sleep & Light

Sponsor:

UCLA

Code:

NCT06678880

Conditions

Depression

Depression During the Menopausal Transition

Menopausal Depression

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Phase Advanced Intervention (PAI)

Phase Delay Intervention (PDI)

Study Details

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

Study ID

NCT06678880

Start date

Mar 11, 2025

Status verified date

Jan, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

Participants assigned to the experimental condition.

active comparator: Group 2

Participants assigned to the active comparator condition.

Interventions

Phase 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.

Phase 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.

Primary outcome measure

  • Urinary 6-sulfatoxymelatonin (6-SMT) [ Time Frame: 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) [ Time Frame: Completed at baseline and after completing two-week intervention. ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Completed at baseline and after completing two-week intervention. ]
  • Sleep Quality Rating (SQR) [ Time Frame: Completed at baseline and after completing two-week intervention. ]

Central Contacts and Locations

Central contacts

Jennifer A Perrott, MSW

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

David Sommerfeld, Ph.D.

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

Locations

University of California San Diego Hillcrest Medical Center

Recruiting

San Diego, California, United States, 92103

Contacts

Barbara L Parry, M.D.

(619) 980-1942bparry@ucsd.edu

David H Sommerfeld, Ph.D.

(858) 472-9397dsommerfeld@health.ucsd.edu

Principal Investigator:

Barbara L Parry, M.D.

More Information

Sponsor

University of California, San Diego

Last update posted

Aug 5, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-08-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.