Sleep Apnea Treatment With Expiratory Resistance(Provent™)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Sleep Apnea, Obstructive
Interventions
DEVICE

Treatment sleep study (Provent™ device used)

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).

OTHER

Baseline sleep study (No device)

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

OTHER

Physiology sleep study (Provent™ on/off)

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.

Trial Locations (1)

21224

Johns Hopkins Asthma and Allergy Center, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ResMed

INDUSTRY

collaborator

Ventus Medical, Inc.

INDUSTRY

lead

Johns Hopkins University

OTHER

NCT01061476 - Sleep Apnea Treatment With Expiratory Resistance(Provent™) | Biotech Hunter | Biotech Hunter