This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.
This is a Phase II randomized controlled trial that will evaluate the effects of supplemental nocturnal oxygen or Positive Airway Pressure (PAP) therapy, compared to optimal medical preventive therapy for Cardiovascular Disease (CVD) risk, on biomarkers of CVD risk in Obstructive Sleep Apnea (OSA) patients at high risk for CVD events. The study will focus on patients with moderate to severe OSA but only mild OSA symptoms. Eligible participants have a history or symptoms of heart disease AND have symptoms of sleep apnea or snoring. Participants will be contributing to medical knowledge about different options that can be used to improve heart disease in people with sleep apnea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
318
Participants randomized to this arm will be educated on PAP and then use PAP for 3 months. They will also receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
Participants randomized to this arm will be educated on nocturnal supplemental oxygen and then use oxygen for 3 months. They also will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
Johns Hopkins University
Baltimore, Maryland, United States
Partners HealthCare
Boston, Massachusetts, United States
VA Boston Healthcare System
Boston, Massachusetts, United States
Case Western Reserve University
Cleveland, Ohio, United States
To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including:
* 24 hour blood pressure (BP) profile * Markers of systemic inflammation * Markers of oxidative stress * Prothrombotic markers * Sympathetic nervous system activity * Cardiac rhythm, impulse generation and ischemia * Dyslipidemia * Glucose regulation * Myocardial stress
Time frame: 3 months
Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including:
* vitality * self reported sleepiness
Time frame: 3 months
Compare nocturnal supplemental oxygen and PAP on measures of:
* efficacy (AHI, hypoxemia) * adherence * side effects
Time frame: 3 months
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Participants randomized to this arm will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.