Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-75
SponsorUniversity of California, San Diego
About this trial
\*\*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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Untreated sleep apnea
Migraine headaches that are triggered or worsened by bright light
Currently suicidal or psychotic
History of bipolar disorder
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: Group 1Experimental treatment 1 intervention
Group B: Group 2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Urinary 6-sulfatoxymelatonin (6-SMT)
Collected to measure melatonin, a hormone that helps regulate your sleep and body clocks.
Time frame
Urine is collected at baseline and after completing two-week intervention.2
Structured Interview Guide for the Hamilton Rating Depression Scale with Atypical Depression Supplement (SIGH-ADS)
A clinician-conducted interview that asks about symptoms of depression, including mood, sleep, appetite, energy, and other emotional and physical symptoms.
Time frame
Completed at baseline and after completing two-week intervention.3
Patient Health Questionnaire (PHQ-9)
A brief questionnaire that asks about common symptoms of depression, such as mood, sleep, energy, appetite, and concentration.
Time frame
Completed at baseline and after completing two-week intervention.4
Sleep Quality Rating (SQR)
A brief questionnaire to rate how well you have been sleeping and whether you have experienced any sleep-related problems.
Time frame
Completed at baseline and after completing two-week intervention.Sponsors and contacts
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Source ClinicalTrials.gov