Clinical trial NCT01061476: Sleep Apnea Treatment With Expiratory Resistance(Provent™)
Official title: Sleep Apnea Treatment With Expiratory Resistance(Provent™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sleep Apnea, Obstructive
Keywords: sleep apnea
treatment
collapsibility
expiratory nasal resistance
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: ResMed
name: Ventus Medical, Inc.
First posted: 2010-02-03
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in AHI
timeFrame: Comparisons were made between the 2 nights
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Susheel Patil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.