CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 450 enrolled
Drug / intervention
Positive Airway Pressure During Sleep (ResMed S9 Elite) +1 moredevice
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/NCT01578031
NCT01578031N/ACompleted

Responses to CPAP Treatment in Obese and Lean Sleep Apnea Patients

University of Pennsylvania·interventional·Posted Apr 16, 2012·Updated Jul 5, 2019

In Brief

A clinical study evaluating Positive Airway Pressure During Sleep (ResMed S9 Elite) and Usual Care for Sleep Apnea and Obesity. Completed, enrolled 450 participants across 1 site.

Detailed Summary

The investigators' overall goal is to compare the effect of CPAP treatment on intermediate cardiovascular risk measures in obese versus lean patients with obstructive sleep apnea (OSA). The overall hypothesis is that, adjusting for OSA severity and obtaining normative data from non-OSA subjects with comparable amounts of visceral adiposity, the two OSA groups will have comparable improvements in daytime sleepiness, but that the cardiovascular and metabolic improvements following CPAP therapy will be decreased in OSA patients with increased visceral adipose tissue. The investigators anticipate that, although there will be a greater absolute change in markers of sympathetic activity, inflammation and oxidative stress in obese compared to lean OSA patients following CPAP treatment, the levels will still be abnormally high in the obese patients resulting in the decreased improvements in insulin resistance, arterial blood pressure, and vascular health in obese versus lean OSA patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea, Obesity
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 16, 2012
Enrollment StartMar 1, 2009
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.2 years ago

Interventions

Positive Airway Pressure During Sleep (ResMed S9 Elite)device

Positive airway pressure during sleep (ResMed S9 Elite).

Usual Careother

Usual care.