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| Name | Class |
|---|---|
| ResMed | INDUSTRY |
| Ventus Medical, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 .
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susheel Patil, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18853699 | Background | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | events/h | Comparisons were made between the 2 nights |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susheel Patil | Johns Hopkins University | 410-550-0574 | spatil@jhmi.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| 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. |
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| 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. |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 12 |
| 0 |
| 12 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |