Heart Biomarker Evaluation in Apnea Treatment

Phase 2

Completed

• Conditions: Cardiovascular Disease; Obstructive Sleep Apnea; Coronary Artery Disease
• Interventions: Other: Healthy Lifestyles and Sleep Education plus PAP; Other: Healthy Lifestyles and Sleep Education plus Supplemental Oxygen; Other: Healthy Lifestyles and Sleep Education

• Registration Number: NCT01086800
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2012-01
• Study Completion: 2012-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HLSE plus PAP	Healthy Lifestyles and Sleep Education plus PAP	-
HLSE plus Oxygen	Healthy Lifestyles and Sleep Education plus Supplemental Oxygen	-
Healthy Lifestyles and Sleep Education	Healthy Lifestyles and Sleep Education	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Partners HealthCare; 🇺🇸 Boston, Massachusetts, United States

VA Boston Healthcare System; 🇺🇸 Boston, Massachusetts, United States