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Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight and Obesity

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Conditions

Overweight or Obesity

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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 goal of this study is to see the effect that a cooling pillow pad called Moona has on sleep quality.

Official Title

Randomized Double-Blind Pilot Study to Examine the Effects of a Localized Body Cooling Technology on Sleep and Metabolism in African, American With Overweight and Obesity

Quick Facts

Study Start:2024-03-25
Study Completion:2025-08-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05849181

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:21 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * African American men and women
  2. * Aged 21-50 years
  3. * BMI ≥ 27 to 45 kg/m2
  4. * Self-report of short or poor sleepers (\>5 \< 7hrs /night and/or a score \> 5 on the PSQI),
  5. * Sleeping between 22:00 and 08:00.
  6. * Ability to provide informed consent before any trial-related activities
  7. * Controlled hypertension or dyslipidemia.
  1. * Previous diagnosis or reveled during the screening PSG (Polysomnography) of obstructive sleep apnea (AHI≥30) or other sleep disorders based on DSM-V (Diagnostic and Statistical Manual of Mental Disorders, fifth edition) criteria.
  2. * Shift work
  3. * Diagnosis of diabetes based on history or screening tests
  4. * History of cognitive or other neurological disorders
  5. * History of major psychiatric disorder based on DSM-V criteria
  6. * Presence of unstable or serious medical conditions
  7. * Use within the past month of melatonin, psychoactive, hypnotic, stimulant or pain medications (except occasionally)
  8. * Caffeine consumption of greater than 500 mg per day
  9. * Medically managed weight loss program within the past 6 months
  10. * History of bariatric weight loss surgery.
  11. * Women who are pregnant, plan on becoming pregnant, are breastfeeding,
  12. * Men or women who have a child at home that does not sleep through the night.
  13. * Active drug/alcohol dependence or abuse

Contacts and Locations

Principal Investigator

Silvana Pannain, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Silvana Pannain, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

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 Date2024-03-25
Study Completion Date2025-08-12

Study Record Updates

Study Start Date2024-03-25
Study Completion Date2025-08-12

Terms related to this study

Additional Relevant MeSH Terms

  • Overweight or Obesity