CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 318 enrolled
Drug / intervention
Healthy Lifestyles and Sleep Education plus PAP +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01086800
NCT01086800Phase 2Completed
CompareCT.gov

Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity

Brigham and Women's Hospital·interventional·Posted Mar 15, 2010·Updated Feb 25, 2013

In Brief

A Phase 2 clinical trial evaluating Healthy Lifestyles and Sleep Education plus PAP, Healthy Lifestyles and Sleep Education plus Supplemental Oxygen, and 1 other intervention for Cardiovascular Disease and 2 related conditions. Completed, enrolled 318 participants across 4 sites.

Detailed Summary

This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Disease, Obstructive Sleep Apnea, Coronary Artery Disease
CountriesUnited States
CollaboratorsCase Western Reserve University, Partners HealthCare, Johns Hopkins University, VA Boston Healthcare System

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJan 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.3 years ago

Interventions

Healthy Lifestyles and Sleep Education plus PAPother

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.

Healthy Lifestyles and Sleep Education plus Supplemental Oxygenother

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.

Healthy Lifestyles and Sleep Educationother

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.