Sleep Apnea Treatment With Expiratory Resistance(Provent™) (SATER)
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Sleep Apnea Treatment With Expiratory Resistance(Provent™)|
- Change in AHI [ Time Frame: one night ] [ Designated as safety issue: No ]
- Quantitative airflow [ Time Frame: 1 night ] [ Designated as safety issue: No ]
- Changes in lung volume [ Time Frame: 1 night ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Single arm - Sleep apnea
All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.
Provent™ is an expiratory nasal resistance device applied to the nares via adhesive.
|United States, Maryland|
|Johns Hopkins Asthma and Allergy Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Susheel Patil, MD, PhD||Johns Hopkins University|