Sleep Apnea Treatment With Expiratory Resistance(Provent™) (SATER)
|ClinicalTrials.gov Identifier: NCT01061476|
Recruitment Status : Completed
First Posted : February 3, 2010
Results First Posted : July 8, 2013
Last Update Posted : July 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sleep Apnea Treatment With Expiratory Resistance(Provent™)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061476
|United States, Maryland|
|Johns Hopkins Asthma and Allergy Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Susheel Patil, MD, PhD||Johns Hopkins University|