Sleep Apnea, Obstructive
Conditions
Keywords
sleep apnea, treatment, collapsibility, expiratory nasal resistance
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.
Interventions
DEVICETreatment 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).
OTHERBaseline 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.
OTHERPhysiology 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.
Sponsors
ResMed
Ventus Medical, Inc.
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
The study was conducted between 2010 and 2011. Patients were primarily recruited from the JH Sleep Disorders Center with a NREM RDI \>= 10/h and \>=90% of events were considered obstructive. 17 subjects met eligibility criteria with 12 enrolled.
Pre-assignment details
Subjects were brought in for an evaluation prior to study enrollment to see if they would tolerate the Provent device by lying down with the device in place for 15-20 minutes.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Single Arm - Sleep Apnea |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age Continuous | 48.3 years STANDARD_DEVIATION 18.2 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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).
Time frame: Comparisons were made between the 2 nights
Population: Although all participants went through the sleep studies, there was insufficient data in 1 subject to assess sleep apnea severity and was therefore excluded from analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm - Sleep Apnea | Change in AHI | Baseline AHI | 45 events/h | Standard Deviation 38 |
| Single Arm - Sleep Apnea | Change in AHI | Change in AHI | -15.8 events/h | Standard Deviation 18.02 |