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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Phase Advanced Intervention (PAI)
BehavioralPhase-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)
BehavioralPhase-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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Active Comparator GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Urine-based 6-sulfatoxymelatonin (6-SMT)
Change in melatonin onset, offset, and acrophase.
Time frame
Baseline and after completing two-week intervention.2
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.
Time frame
Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.3
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.
Time frame
Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.4
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.
Time frame
Baseline and after completing two-week intervention; sustained at two weeks post intervention completion through three months post intervention completion.Sponsors and contacts
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Source ClinicalTrials.gov