Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-05-20
2026-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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No Intervention (Aim 1) Group
Participants in this group will not receive an intervention and will only undergo several testing procedures conducted within 3 to 4 weeks to assess OSA severity.
No interventions assigned to this group
PAP Therapy and Lifestyle Intervention (Aim 2) Group
Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive the PAP therapy and Lifestyle Intervention for 12 weeks.
PAP Therapy
Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use
Lifestyle Counseling Intervention
Lifestyle intervention will include counseling on (a) education on nutrition and exercise; and (b) behavioral support for identifying lifestyle change strategies and problem-solving barriers to improve the regularity and duration of sleep. This will be conducted using brochures on weight loss and sleep hygiene
Lifestyle Intervention Only (Aim 2) Group
Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive only the Lifestyle Intervention for 12 weeks.
Lifestyle Counseling Intervention
Lifestyle intervention will include counseling on (a) education on nutrition and exercise; and (b) behavioral support for identifying lifestyle change strategies and problem-solving barriers to improve the regularity and duration of sleep. This will be conducted using brochures on weight loss and sleep hygiene
Interventions
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PAP Therapy
Auto-PAP device (ResMed AirsenseTM Autoset) with a heated humidifier will be provided along with an appropriate mask and connecting hose for nightly use
Lifestyle Counseling Intervention
Lifestyle intervention will include counseling on (a) education on nutrition and exercise; and (b) behavioral support for identifying lifestyle change strategies and problem-solving barriers to improve the regularity and duration of sleep. This will be conducted using brochures on weight loss and sleep hygiene
Eligibility Criteria
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Inclusion Criteria
* Ability to provide consent
* 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 the nights during 1-week run-in period
* Successful completion of all of the procedures for Aim 1.
Exclusion Criteria
* 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%
Aim 2 Group:
* 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%
18 Years
70 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Miami
OTHER
Responsible Party
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Naresh Punjabi
Professor
Principal Investigators
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Naresh Punjabi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20210670
Identifier Type: -
Identifier Source: org_study_id