Sleep Apnea Treatment With Expiratory Resistance(Provent™) (SATER)

Johns Hopkins University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sleep Apnea, Obstructive

Treatments: Device: Treatment sleep study (Provent™ device used); Other: Baseline sleep study (No device); Other: Physiology sleep study (Provent™ on/off)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01061476

NA_00031257

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Single arm - Sleep apnea

Other group

Description:

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 . 1. Baseline sleep study (No device) - Assess the effects of no Provent™ on sleep apnea severity. 2. Treatment sleep study (Provent™ device used) - Assess the effects of Provent™ on sleep apnea severity 3. Physiology sleep study (Provent™ on/off) - Assess the physiological effects of the Provent™ device on breathing during sleep.

Treatment:

Device: Treatment sleep study (Provent™ device used)

Other: Physiology sleep study (Provent™ on/off)

Other: Baseline sleep study (No device)