NCT01061476

Sleep Apnea Treatment With Expiratory Resistance(Provent™)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-02-03
• Last updated: 2013-07-19
• Results posted: 2013-07-08

Locations

1 site across 1 country: United States