At a glance

ClinicalIndex Comparison Record

N/ACompleted· 181 enrolled

Drug / intervention

Weight Loss Program +1 morebehavioral

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/NCT00371293

NCT00371293N/ACompleted

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Inflammatory Response to Sleep Apnea in Obese Subjects: The Cardiovascular Effects of Obstructive Sleep Apnea (COSA) Study

University of Pennsylvania·interventional·Posted Sep 4, 2006·Updated Apr 5, 2017

In Brief

A clinical study evaluating Weight Loss Program and CPAP therapy for Sleep Apnea Syndromes and Inflammation. Completed, enrolled 181 participants across 2 sites.

Detailed Summary

Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person's breathing is restricted during sleep. Obese individuals with OSA are at an increased risk of inflammation and heart conditions, but it is unknown whether this risk is related to the effects of OSA or obesity. This study will evaluate whether OSA or obesity plays the primary role in inflammation related to heart disease. The study will also determine the independent effects of OSA and obesity on insulin resistance and blood vessel function.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSleep Apnea Syndromes, Inflammation

CountriesUnited States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2006

First PostedSep 2006

Primary CompletionSep 2012

Study CompletionDec 2013

TodayJul 2026

First PostedSep 4, 2006

Enrollment StartSep 1, 2006

Primary CompletionSep 1, 2012

Study CompletionDec 1, 2013

TodayJul 2, 2026

Enrollment to primary: 6 yearsPosted 19.8 years ago

Interventions

Weight Loss Programbehavioral

Participants in the weight loss program will receive weekly dietary counseling and will be encouraged to decrease caloric intake and increase physical activity.

CPAP therapydevice

Participants receiving CPAP therapy will use a CPAP machine each night while they sleep.