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Tart Cherry Juice for Sleep in Older Adults With Insomnia: A Pilot Study of Feasibility and Comprehensive Mechanisms

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Conditions

Sleep ProblemsInsomniaMontmorencycherryflavonoidssleep quality

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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 purpose of this research study is test if a study that asks older adults with sleep problems to consume tart cherry products is feasible and determine if it can change sleep patterns. This study is a total of 12 weeks. Participants will be asked to consume tart cherry juice for 4 weeks and the placebo juice for 4 weeks, while wearing a digital monitor that measures sleep. Blood (about 3 teaspoons) and urine (about 2 tablespoons) samples will be taken before and after consuming both juices to measure certain biological markers related to sleep.

Official Title

Tart Cherry Juice for Sleep in Older Adults With Insomnia: A Pilot Study of Feasibility and Comprehensive Mechanisms

Quick Facts

Study Start:2025-01-15
Study Completion:2025-08-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06786494

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:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women aged ≥65 years
  2. * Self-reporting insomnia (e.g., trouble sleeping approximately 3 nights a week for at least 6 months and/or an Insomnia Severity Index score ≥ 10 points)
  3. * Usual bed-time between 8:00 pm and 1:00 am
  1. * Unwilling to follow the study protocol
  2. * Inability to properly use the wearable device, complete smartphone-based surveys, or follow the intervention protocol
  3. * Self-report of medically diagnosed sleep disorders except insomnia (e.g., sleep apnea)
  4. * Current and consistent use of sleep aids or hypnotic prescriptions (e.g., trazadone)
  5. * Self-report of cognitive impairment, dementia, or other neurological disorder
  6. * Are on unstable medications (i.e., change within the last 3 months) for other conditions
  7. * Have an allergy to the intervention products
  8. * Self-report history of diabetes
  9. * Current alcohol (Alcohol Use Disorders Identification Test ≥4 points33,34) or drug use disorder (Drug Abuse Screening Test,35,36 DAST-10\>2 points)
  10. * Are excessive caffeine drinkers (\>5 cups of caffeinated beverages a day)
  11. * Any other reason/condition the PI and investigative team believe this intervention would be unsafe

Contacts and Locations

Principal Investigator

Courtney Millar, PhD
PRINCIPAL_INVESTIGATOR
Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School

Study Locations (Sites)

Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
United States

Collaborators and Investigators

Sponsor: Courtney Millar

  • Courtney Millar, PhD, PRINCIPAL_INVESTIGATOR, Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School

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 Date2025-01-15
Study Completion Date2025-08-13

Study Record Updates

Study Start Date2025-01-15
Study Completion Date2025-08-13

Terms related to this study

Keywords Provided by Researchers

  • Montmorency
  • cherry
  • flavonoids
  • sleep quality

Additional Relevant MeSH Terms

  • Sleep Problems
  • Insomnia