CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Treatment sleep study (Provent™ device used) +2 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/NCT01061476
NCT01061476Phase 2Completed
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Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Johns Hopkins University·interventional·Posted Feb 3, 2010·Updated Jul 19, 2013

In Brief

A Phase 2 clinical trial evaluating Treatment sleep study (Provent™ device used), Baseline sleep study (No device), and 1 other intervention for Sleep Apnea, Obstructive. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the current study is to examine how well the Provent™ device treats OSA with particular attention to the how the it may treat sleep apnea and who may most likely benefit from the use of this treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea, Obstructive
CountriesUnited States
CollaboratorsResMed, Ventus Medical, Inc.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2010
Enrollment StartJan 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.4 years ago

Interventions

Treatment sleep study (Provent™ device used)device

The patient's sleep apnea severity is determined on this night while using the Provent™ device. The patient only uses the Provent™ device on this night (single night use only).

Baseline sleep study (No device)other

The patient sleeps for 1 night in the sleep lab to determine their baseline sleep apnea severity without sleeping with the Provent device.

Physiology sleep study (Provent™ on/off)other

During this sleep study night, the patient is sleeping with a modified Provent™ device that can be turned on and off to assess changes in airflow during the night (single night use only).Provent™ on/off is bracketed in 10 minute intervals during stable stage 2 sleep.