Sleep Apnea Treatment With Expiratory Resistance(Provent™)

NCT01061476 | Completed Phase 1 Results

• 1 other identifier: NA_00031257
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

sleep apnea; treatment; collapsibility; expiratory nasal resistance

Outcome Measures

Primary Outcomes (1)

• Change in AHI

  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).

  Comparisons were made between the 2 nights

Study Arms (1)

Single arm - Sleep apnea

OTHER

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.

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

Interventions

Treatment sleep study (Provent™ device used) 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).

Single arm - Sleep apnea

Baseline sleep study (No device) OTHER

The patient sleeps for 1 night in the sleep lab to determine their baseline sleep apnea severity without sleeping with the Provent device.

Single arm - Sleep apnea

Physiology sleep study (Provent™ on/off) 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.

Single arm - Sleep apnea

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• ResMed: collaborator
• Ventus Medical, Inc.: collaborator

Study Sites (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• 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.

  PMID: 18853699 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

* Small sample size and limited power for analysis. * Oral breathing during expiratory nasal resistance (ENR) confounds the mechanism of action.

Results Point of Contact

• Title: Dr. Susheel Patil
• Organization: Johns Hopkins University

spatil@jhmi.edu

410-550-0574

Study Officials

• Susheel Patil, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 19, 2013
• Results First Posted: July 8, 2013

Record last verified: 2013-07

Locations

US (1)