Sleep Apnea Treatment With Expiratory Resistance(Provent™) (SATER)
This study has been completed.
Sponsor:
Johns Hopkins University
Collaborators:
ResMed
Ventus Medical, Inc.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01061476
First received: February 2, 2010
Last updated: June 27, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive |
Device: Provent™ |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Sleep Apnea Treatment With Expiratory Resistance(Provent™) |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Change in AHI [ Time Frame: one night ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quantitative airflow [ Time Frame: 1 night ] [ Designated as safety issue: No ]
- Changes in lung volume [ Time Frame: 1 night ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Single arm - Sleep apnea
All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.
|
Device: Provent™
Provent™ is an expiratory nasal resistance device applied to the nares via adhesive.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061476
Locations
| United States, Maryland | |
| Johns Hopkins Asthma and Allergy Center | |
| Baltimore, Maryland, United States, 21224 | |
Sponsors and Collaborators
Johns Hopkins University
ResMed
Ventus Medical, Inc.
Investigators
| Principal Investigator: | Susheel Patil, MD, PhD | Johns Hopkins University |
More Information
Publications:
| Responsible Party: | Susheel Patil, M.D., Ph.D., Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01061476 History of Changes |
| Other Study ID Numbers: | NA_00031257 |
| Study First Received: | February 2, 2010 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
sleep apnea treatment collapsibility expiratory nasal resistance |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013