Phase
Condition
Sleep Apnea Syndromes
Treatment
Lifestyle Counseling Intervention
PAP Therapy
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Aim 1 Group:
Inclusion criteria:
Age between 18-70 years
Ability to provide consent
Exclusion criteria
Body Mass Index (BMI) > 40 kg/m2
Prevalent myocardial infarction, coronary revascularization, heart failure, andstroke
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 orresistant hypertension, severe chronic obstructive pulmonary disease, cancer, andactive psychiatric disease (e.g., major depression)
Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleepduration < 6h)
Use of supplemental oxygen during wakefulness or sleep
Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respirationbased on the home sleep test
Resting awake Oxygen Saturation (SpO2) < 90%
Aim 2 Group:
Inclusion criteria:
Age between 18-70 years
Ability to provide consent
Moderate-to-severe OSA (AHI ≥ 15/h);
Demonstration of Positive Airway Pressure (PAP) use of > 4 h/night on 70% of thenights during 1-week run-in period
Successful completion of all of the procedures for Aim 1.
Exclusion
Exclusion criteria:
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 sleepinesswithin 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 orresistant hypertension, severe chronic obstructive pulmonary disease, cancer, andactive psychiatric disease (e.g., major depression)
Other sleep disorders (e.g., circadian rhythm disorder, self-reported habitual sleepduration < 6h)
Use of supplemental oxygen during wakefulness or sleep
Central sleep apnea, obesity hypoventilation syndrome or Cheyne-Stokes respirationbased on the home sleep test
Resting awake SpO2 < 90%
Study Design
Connect with a study center
University of Miami
Miami, Florida 33143
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.