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The Effects of Treating Obese and Lean Patients With Sleep Apnea

NCT01578031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2019-07-05

Study results available
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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.

Conditions

Interventions

DEVICE

Positive Airway Pressure During Sleep (ResMed S9 Elite)

Positive airway pressure during sleep (ResMed S9 Elite).

OTHER

Usual Care

Usual care.

Sponsors & Collaborators

Principal Investigators

  • Samuel Kuna, MD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01578031 on ClinicalTrials.gov