RECRUITING

Chronobiological Basis of Menopausal Depression: Correcting Misaligned Circadian Rhythms with Sleep and Light Interventions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Chronobiological Basis of Depression During the Menopause Transition

Quick Facts

Study Start:2025-02-21
Study Completion:2029-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06678880

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Perimenopausal women with irregular menstrual cycles for at least 3 months
  2. * Above age 18
  3. * Experiencing at least moderate depression symptoms (i.e., score of at least 10 on PHQ-9)
  1. * Actively suicidal or psychotic
  2. * History of bipolar disorder
  3. * Staring new medications that would affect outcome measures (e.g., melatonin)
  4. * Those in whom sleep restriction would be ill-advised (e.g., patients with epilepsy or those with occupations whose safety would be compromised).
  5. * Women whose body mass index (BMI) exceeds the NIH criteria of \<18 or \> than 30

Contacts and Locations

Study Contact

Jennifer A Perrott, MSW
CONTACT
(407) 619-9441
jperrott@health.ucsd.edu
David Sommerfeld, Ph.D.
CONTACT
(407) 966-7703
dsommerfeld@health.ucsd.edu

Principal Investigator

Barbara Parry, M.D.
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

University of California San Diego Hillcrest Medical Center
San Diego, California, 92103
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Barbara Parry, M.D., PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-21
Study Completion Date2029-02-28

Study Record Updates

Study Start Date2025-02-21
Study Completion Date2029-02-28

Terms related to this study

Keywords Provided by Researchers

  • Menopause
  • depression
  • sleep and light intervention
  • melatonin
  • circadian rhythm
  • Chronobiology

Additional Relevant MeSH Terms

  • Depression
  • Depression During the Menopausal Transition
  • Menopausal Depression