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

This study has been completed.
Sponsor:
Collaborators:
ResMed
Ventus Medical, Inc.
Information provided by (Responsible Party):
Susheel Patil, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01061476
First received: February 2, 2010
Last updated: July 9, 2013
Last verified: July 2013
  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: Treatment sleep study (Provent™ device used)
Other: Baseline sleep study (No device)
Other: Physiology sleep study (Provent™ on/off)
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: Comparisons were made between the 2 nights ] [ Designated as safety issue: No ]
    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).


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

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)
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).
Other: 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.
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01061476     History of Changes
Other Study ID Numbers: NA_00031257
Study First Received: February 2, 2010
Results First Received: September 20, 2012
Last Updated: July 9, 2013
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 August 01, 2014