Sleep Apnea Treatment With Expiratory Resistance(Provent™)

NCT ID: NCT01061476

Last Updated: 2013-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-01-31

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Single arm - Sleep apnea

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.

Group Type: OTHER

Treatment sleep study (Provent™ device used)

Intervention Type: DEVICE

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).

Baseline sleep study (No device)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: collaborator

Ventus Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Susheel Patil

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susheel Patil, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18853699 (View on PubMed)

Other Identifiers

NA_00031257

Identifier Type: -

Identifier Source: org_study_id