CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Continuous positive airway pressure +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/NCT01629862
NCT01629862Phase 2Completed
CompareCT.gov

Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea.

Sanjay R Patel·interventional·Posted Jun 28, 2012·Updated May 28, 2019

In Brief

A Phase 2 clinical trial evaluating Continuous positive airway pressure and Sham continuous positive airway pressure for Sleep Apnea, Obstructive and Diabetes Mellitus. Completed, enrolled 53 participants across 2 sites.

Detailed Summary

The investigators will examine the possible synergistic effects of obstructive sleep apnea (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part investigation: * A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy controls. * A three-month randomized placebo-controlled trial of continuous positive airway pressure (CPAP) in subjects with OSA+DM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea, Obstructive, Diabetes Mellitus
CountriesUnited States
CollaboratorsBeth Israel Deaconess Medical Center, Brigham and Women's Hospital, National Institutes of Health (NIH)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 28, 2012
Enrollment StartApr 1, 2012
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.0 years ago

Interventions

Continuous positive airway pressuredevice

CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).

Sham continuous positive airway pressuredevice

CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).