Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Phase Advanced Intervention (PAI)
  • Phase Delay Intervention (PDI)

Treatment groups

120 Participants
are divided into 2 treatment groups