CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
Positive Pressure Therapy (PAP) +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/NCT01503164
NCT01503164N/ACompleted

Sleep, Obesity, and Metabolism in Normal and Overweight Subjects: Effects of CPAP on Glucose Metabolism

Johns Hopkins University·interventional·Posted Jan 2, 2012·Updated Oct 19, 2017

In Brief

A clinical study evaluating Positive Pressure Therapy (PAP) and LifeStyle Counseling for Obstructive Sleep Apnea and 2 related conditions. Completed, enrolled 111 participants across 1 site.

Detailed Summary

Obstructive sleep apnea affects approximately 2-4% of middle-aged adults in the general population and is associated with several medical conditions including hypertension and coronary artery. Research over the last decade has shown that obstructive sleep apnea may also increase the propensity for insulin resistance, glucose intolerance, and type 2 diabetes mellitus. Positive airway pressure (PAP) is the first line therapy for the treatment of obstructive sleep apnea. While PAP therapy has several favorable effects such as improvements in daytime sleepiness and quality of life, it is not clear whether using PAP therapy can alter metabolic risk. The overall objective of this study is to examine whether treatment of obstructive sleep apnea with positive airway pressure therapy improves glucose tolerance and insulin sensitivity. The primary hypothesis of this study is that PAP therapy of obstructive sleep apnea will improve in insulin sensitivity and glucose metabolism.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 2, 2012
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.5 years ago

Interventions

Positive Pressure Therapy (PAP)device

Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.

LifeStyle Counselingbehavioral

Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.