Phase 2 N=12

Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Sleep Apnea, Obstructive

Bottom Line

View on ClinicalTrials.gov: NCT01061476 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Change in AHI — 45; -15.8 events/h

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Treatment sleep study (Provent™ device used) (Device); Baseline sleep study (No device) (Other); Physiology sleep study (Provent™ on/off) (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in AHI	45; -15.8	—

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 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 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

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Data sourced from ClinicalTrials.gov (NCT01061476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.