RECRUITING

Metabolism and Sleep Apnea Treatment

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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 to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.

Official Title

Metabolism and Sleep Apnea Treatment

Quick Facts

Study Start:2022-05-20

Study Completion:2026-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05539716

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 to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age between 18-70 years * Ability to provide consent * Body Mass Index (BMI) \> 40 kg/m2 * Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke * Type 1 or Type 2 diabetes mellitus * Current or prior use of PAP or oral appliance therapy for OSA * Use of oral corticosteroids * Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression) * Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h) * Use of supplemental oxygen during wakefulness or sleep * Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test * Resting awake Oxygen Saturation (SpO2) \< 90%	* BMI: ≥ 40 kg/m2 * Type 1 or Type 2 diabetes mellitus * Current use of PAP or oral appliance therapy for OSA * Commercial driver or report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years * Epworth sleepiness score of 18 or more * Use of oral corticosteroids * Participation in another clinical trial * Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression) * Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h) * Use of supplemental oxygen during wakefulness or sleep * Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test * Resting awake SpO2 \< 90%

Inclusion Criteria

Exclusion Criteria

* Age between 18-70 years
* Ability to provide consent
* Body Mass Index (BMI) \> 40 kg/m2
* Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
* Type 1 or Type 2 diabetes mellitus
* Current or prior use of PAP or oral appliance therapy for OSA
* Use of oral corticosteroids
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
* Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h)
* Use of supplemental oxygen during wakefulness or sleep
* Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test
* Resting awake Oxygen Saturation (SpO2) \< 90%

* BMI: ≥ 40 kg/m2
* Type 1 or Type 2 diabetes mellitus
* Current use of PAP or oral appliance therapy for OSA
* Commercial driver or report of motor vehicle accident or near-miss due to sleepiness within the 2 previous years
* Epworth sleepiness score of 18 or more
* Use of oral corticosteroids
* Participation in another clinical trial
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
* Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleep duration \< 6h)
* Use of supplemental oxygen during wakefulness or sleep
* Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respiration based on the home sleep test
* Resting awake SpO2 \< 90%

Contacts and Locations

Study Contact

Naresh Punjabi, MD

CONTACT

305-243-3963

npunjabi@miami.edu

Principal Investigator

Naresh Punjabi, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33143

United States

Collaborators and Investigators

Sponsor: University of Miami

Naresh Punjabi, MD, PRINCIPAL_INVESTIGATOR, University of Miami

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 Date2022-05-20

Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-05-20

Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

Obstructive Sleep Apnea
Fat Disorder