Sleep and Light Intervention (SALI) for Menopausal Mood Dysfunction

Официальное название

Chronobiological Basis of Depression During the Menopause Transition

Обзор

\*\*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.

Подробное описание

Our bodies naturally follow a 24-hour internal clock that helps regulate sleep, hormones, mood, and energy. During menopause, hormonal changes can disrupt the timing of this internal clock, which may contribute to mood changes, sleep problems, and low energy.

Participants will be asked to change their sleep timing for one night and use bright light at specific times of day for two weeks. In previous studies, some women experienced improvements in mood within days to weeks. SALI does not use medication and has few side effects.

Participants must live in San Diego County. Interested individuals will first complete a screening process to help determine whether this study is a good match for them and whether participation would be appropriate and safe. The screening includes questionnaires and interviews about health, mood, sleep, and mental health history. Not everyone who is screened will qualify to participate.

Study participation is approximately 4 ½ months, and includes:

* 4 weeks of wearing an activity/light wrist sensor * 2 overnight urine collections to measure melatonin, the best measure of human circadian rhythms, and a hormone that helps regulate the timing of sleep * 1 night where the timing and duration of your sleep will be adjusted * 2 weeks of daily light box usage (30 minutes per day at a specified time) and daily surveys to track mood \& side effects * Regularly scheduled Zoom interviews \& online surveys to monitor your mood \& sleep before and after SALI

All study activities can be done from the comfort of your home. Researchers hope this work will lead to new ways to improve mood and sleep during menopause and help identify treatments that can be tailored to each person's biological rhythms.

This is a research study, not a clinical treatment. Participation is confidential and voluntary. Participants may or may not benefit directly from participating. To receive full compensation, participants are required to complete study tasks on scheduled days.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California San Diego Hillcrest Medical Center — San Diego

Идентификаторы

NCT: NCT06678880 · MH134120

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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