Cardiovascular Disease, Coronary Artery Disease, Obstructive Sleep Apnea
Conditions
Brief summary
This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.
Detailed description
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.
Interventions
OTHERHealthy Lifestyles and Sleep Education plus PAP
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.
OTHERHealthy Lifestyles and Sleep Education plus Supplemental Oxygen
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.
OTHERHealthy Lifestyles and Sleep Education
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.
Sponsors
Case Western Reserve University
Partners HealthCare
Johns Hopkins University
VA Boston Healthcare System
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* established Coronary Artery Disease or established cardiovascular disease risk factors * home sleep test that showed moderately severe sleep apnea
Exclusion criteria
* poorly controlled health * currently using supplemental oxygen or PAP for OSA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including: | 3 months | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including: | 3 months | * vitality * self reported sleepiness |
| Compare nocturnal supplemental oxygen and PAP on measures of: | 3 months | * efficacy (AHI, hypoxemia) * adherence * side effects |
Countries
United States
Outcome results
None listed