Sleep Apnea Treatment With Expiratory Resistance(Provent™) (SATER)
|Sleep Apnea, Obstructive||Device: Treatment sleep study (Provent™ device used) Other: Baseline sleep study (No device) Other: Physiology sleep study (Provent™ on/off)||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Official Title:||Sleep Apnea Treatment With Expiratory Resistance(Provent™)|
- Change in AHI [ Time Frame: Comparisons were made between the 2 nights ]The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI > 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and > 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).
|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
Participants with sleep apnea will be recruited for the study. Each participant will undergo 3 sleep studies to assess the effect of the Provent™ device. Participants will only use the device while they are in the sleep laboratory. They will not use the device at home between sleep studies .
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061476
|United States, Maryland|
|Johns Hopkins Asthma and Allergy Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Susheel Patil, MD, PhD||Johns Hopkins University|