Heart Biomarker Evaluation in Apnea Treatment

Study Overview
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Brief Summary
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This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.

Detailed Description
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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.

Official Title
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Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity

Conditions
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Cardiovascular Disease, Obstructive Sleep Apnea, Coronary Artery Disease

Intervention / Treatment
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* Other: Healthy Lifestyles and Sleep Education plus PAP
* Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen
* Other: Healthy Lifestyles and Sleep Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HLSE plus PAP<br> | Other: Healthy Lifestyles and Sleep Education plus PAP<br>* 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.<br>|
| Other: HLSE plus Oxygen<br> | Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen<br>* 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.<br>|
| Other: Healthy Lifestyles and Sleep Education<br> | Other: Healthy Lifestyles and Sleep Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including: | vitality self reported sleepiness | 3 months | 
| Compare nocturnal supplemental oxygen and PAP on measures of: | efficacy (AHI, hypoxemia) adherence side effects | 3 months |