Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Sleep Apnea, Obstructive Clinical Trial

— SATER  

Official title:

Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061476
• Other study ID #: NA_00031257
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 2, 2010
• Last updated: July 9, 2013
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: July 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Consenting adults over the age of 18

• Diagnosed obstructive sleep apnea (defined as an RDI > 5 events per hour & = 90% of disordered breathing events classified as obstructive)

Exclusion Criteria:

• Total sleep time from previous sleep study < 4 hours (240 minutes)

• Severe bilateral nasal obstruction (apparent mouth breathing at rest)

• Documented history of lung diseases, as defined below:

• Daytime hypercapnia (PaCO2 > 45 mmHg)

• Baseline SaO2 = 92%

• Chronic lung disease except mild intermittent or mild persistent asthma

• Cor pulmonale

• Documented clinical cardiovascular disease, as defined below:

• Myocardial infarction in past 3 months

• Revascularization procedure in past 3 months

• Implanted cardiac pacemaker or ICD

• Unstable arrhythmias

• Congestive heart failure with ejection fraction < 40%

• Uncontrolled hypertension (BP > 190/110)

• History of end stage renal disease (on dialysis)

• History of end stage liver disease, such as:

• Jaundice

• Ascites

• History of recurrent gastrointestinal bleeding

• Transjugular intrahepatic portosystemic shunt (TIPS) ;

• Sleep disorders other than obstructive sleep apnea, such as:

• Narcolepsy

• Restless leg syndrome

• Periodic limb movements causing an arousal index of > 5 per hour

• Transportation industry worker (commercial truck or bus drivers, airline pilots)

• Known pregnancy (by self report)

• Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin.

• Allergy to lidocaine

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Asthma and Allergy Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	ResMed, Ventus Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Colrain IM, Brooks S, Black J. A pilot evaluation of a nasal expiratory resistance device for the treatment of obstructive sleep apnea. J Clin Sleep Med. 2008 Oct 15;4(5):426-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in AHI	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).	Comparisons were made between the 2 nights	No