Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction

What this trial studies

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.

Conditions in scope

• Depression
• Depression During the Menopausal Transition
• Menopausal Depression

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.
• 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.

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

• 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)

Exclusion criteria

• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-03-11
• Primary completion: 2028-12
• Last update posted: 2026-02-27
• First posted: 2024-11-07

Sponsor & contact

Lead sponsor: University of California, San Diego (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Urine-based 6-sulfatoxymelatonin (6-SMT) (Baseline and after completing two-week intervention.)
  Change in melatonin onset, offset, and acrophase.
• Structured Interview Guide for the Hamilton Rating Depression Scale with Atypical Depression Supplement (SIGH-ADS) (Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.)
  Clinicians rate change in mood on a numerical scale where 0= little/no symptoms and a higher number indicates increased symptoms or impairment.
• Patient Health Questionnaire (PHQ-9) (Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.)
  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.
• Sleep Quality Rating (SQR) (Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.)
  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.
• Objective Measures of Sleep (Continuous monitoring from one week prior to baseline through one week post intervention completion.)
  Change in sleep timing and duration (objectively measured via continuously worn MotionWatch device)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.