Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Phase 1

Completed

Conditions: Sleep Apnea, Obstructive

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

Registration Number: NCT01061476

Lead Sponsor: Johns Hopkins University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm - Sleep apnea	Treatment sleep study (Provent™ device used)	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.
Single arm - Sleep apnea	Baseline sleep study (No device)	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.
Single arm - Sleep apnea	Physiology sleep study (Provent™ on/off)	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.

Primary Outcome Measures

Name	Time	Method
Change in AHI	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).

Secondary Outcome Measures