Obstructive Sleep Apnea HypopneaPhase 4AERONCT00772044
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
A Phase 4 study testing Provent Professional Sleep Apnea Therapy Device in people with Obstructive Sleep Apnea Hypopnea and OSA, run by Ventus Medical, Inc. at 17 sites in United States.
Trial summary
Primary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine) Secondary Endpoints: By polysomnography, reduction in: AHI with device on vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Hypopnea, OSA, OSAH
- What is being tested?
- Provent Professional Sleep Apnea Therapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2008to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Diagnosis of OSA
- AHI > 10 on diagnostic PSG performed within last 3 months
- Investigator believes that subject can benefit from OSA tx
- Subject understands and is willing and able to comply with study requirements
Who cannot join
- Use of any device that interferes with nasal/oral breathing
- Persistent blockage of one or both nostrils
- Any chronic sores or lesions on the inside/outside of the nose
- Chronic use of nasal decongestants other than nasal steroids
- Oxygen saturation < 75% for > 10% of the diag. PSG
- Oxygen saturation < 75% for > 25% of the first 4 hours of the diag. PSG
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- Prior or near-miss motor vehicle accident due to sleepiness (last 12 mo.)
- Current use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect neurocognitive function and/or alertness
- History of allergic reaction to acrylic-based adhesives
- Current acute upper respiratory inflammation/infection or perforation of the tympanic membrane
- History of frequent and/or poorly treated severe nasal allergies or sinusitis
- Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior disorder or any other diagnosed or suspected sleep disorder
- Current use of diurnal or nocturnal supplemental oxygen
- History of CPAP use in the home for OSA tx
- History of use of oral appliances for OSA tx
- History of prior surgery for OSA
- Currently working night or rotating shifts
- Consumption of > 10 caffeinated beverages per day
- History of severe cardiovasc. disease, including NYHA Class III or IV heart failure, CAD with angina or MI/stroke in past 6 months
- History of cardiac rhythm disturbance
- Uncontrolled hypertension (SBP > 180 or DBP > 105 mm Hg)
- Uncontrolled hypotension(SBP < 80 or DBP < 55 mm Hg
- History of severe respiratory disorders or unstable respiratory disease
- Any other serious, uncontrolled medical condition
- Females of child bearing age who are pregnant or intending to become pregnant
- Consumes more than 3 drinks of alcohol/day
- Chronic neurologic disorders
- Cancer, unless in remission for more than 1 year
- Current psychiatric illness
- Smokers whose habit interferes with the overnight PSG
- Any known illicit drug usage
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342
Sleep Health Center
Brighton, Massachusetts, 02135
Sleep Medicine and Research Center
Chesterfield, Missouri, 63017
SleepMed of South Carolina
Columbia, South Carolina, 29201
The Corvallis Clinic
Corvallis, Oregon, 97330
Sleep Medicine Associates of Texas
Dallas, Texas, 75231
Wayne State University
Detroit, Michigan, 48201
Chicago Sleep Group of Suburban Lung Associates
Elk Grove Village, Illinois, 60007
University Of Florida College of Medicine
Gainesville, Florida, 32610
Pulmonary Associates
Glendale, Arizona, 85306
Borgess Research Institute
Kalamazoo, Michigan, 49048
Kentucky Research Group
Louisville, Kentucky, 40217
Pulmonary Associates
Phoenix, Arizona, 85006
Stanford Center for Human Sleep Research
Redwood City, California, 94063
Mayo Clinic
Rochester, Minnesota, 55905
Sleep Therapy and Research Center
San Antonio, Texas, 07829
Gaylord Sleep Medicine
Wallingford, Connecticut, 06492
About this study
Official title: Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH
Primary Endpoints:
•Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)
Secondary Endpoints: By polysomnography, reduction in:
- AHI with device on vs. off at 3 months, controlling for sleep position
- Oxygen desaturation index with device on vs. off
- Arousal index with device on vs. off
- Duration of snoring with device on vs. off
- Epworth Sleepiness Scale
Patient acceptance, in terms of:
- Refusal rate at screening
- Discontinuation rate during follow-up
- Daily compliance rate
- Device-related adverse events
- Serious adverse events
Read the detailed description
Please see summary above
- Conditions
- Obstructive Sleep Apnea Hypopnea, OSA, OSAH
- Being tested
- Provent Professional Sleep Apnea Therapy Device, Sham Device
- Keywords
- OSA, sleep apnea, apnea, AHI
- Medical subject headings
- Sleep Apnea Syndromes, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provent Professional Sleep Apnea Therapy DeviceDevice
Also called Provent
Application of active device (Provent)
Sham DeviceDevice
Sham device will be applied
| Study group | Role | What they receive |
|---|---|---|
| Provent | Active comparator | Those receiving the active device Receives: Device: Provent Professional Sleep Apnea Therapy Device |
| Sham | Sham comparator | Those receiving sham device Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)
Measured: 3 months
Secondary outcomes (1)
Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea HypopneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard B Berry, M.D., Principal investigator, University of FloridaConnie A Rey, Study director, Ventus Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772044
- Sponsor's protocol ID
- C009
- Acronym
- AERO
- Status last verified
- Mar 2010
- First submitted
- 13 Oct 2008
- Last updated
- 1 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep. 2011 Apr 1;34(4):479-85. doi: 10.1093/sleep/34.4.479.
PubMed 21461326
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH
- ClinicalTrials.gov ID
- NCT00772044
- Acronym / sponsor ID
- AERO / C009
- Conditions
- Obstructive Sleep Apnea Hypopnea, OSA, OSAH
- Keywords
- OSA, sleep apnea, apnea, AHI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ventus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Endpoints:
•Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)
Secondary Endpoints: By polysomnography, reduction in:
- AHI with device on vs. off at 3 months, controlling for sleep position
- Oxygen desaturation index with device on vs. off
- Arousal index with device on vs. off
- Duration of snoring with device on vs. off
- Epworth Sleepiness Scale
Patient acceptance, in terms of:
- Refusal rate at screening
- Discontinuation rate during follow-up
- Daily compliance rate
- Device-related adverse events
- Serious adverse events
Detailed description
Please see summary above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provent | Active comparator | Device: Provent Professional Sleep Apnea Therapy DeviceThose receiving the active device |
| Sham | Sham comparator | Device: Sham DeviceThose receiving sham device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Diagnosis of OSA
- AHI > 10 on diagnostic PSG performed within last 3 months
- Investigator believes that subject can benefit from OSA tx
- Subject understands and is willing and able to comply with study requirements
Key exclusion criteria (31 listed)
- Use of any device that interferes with nasal/oral breathing
- Persistent blockage of one or both nostrils
- Any chronic sores or lesions on the inside/outside of the nose
- Chronic use of nasal decongestants other than nasal steroids
- Oxygen saturation < 75% for > 10% of the diag. PSG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provent Professional Sleep Apnea Therapy DeviceAlso: ProventApplication of active device (Provent) | Device | Provent |
| Sham DeviceSham device will be applied | Device | Sham |
Primary outcome
Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)
Time frame: 3 months
1 secondary outcome
Reduction in AHI, Oxygen desat index, Arousal index & Duration of snoring w/ device on/off;ESS,Patient acceptance,Device-related AEs & SAEs
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2010.
- Derived from this study: PubMed 21461326Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep. 2011 Apr 1;34(4):479-85. doi: 10.1093/sleep/34.4.479.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Berry, M.D. principal investigator
University of Florida
Connie A Rey study director
Ventus Medical
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Provent Professional Sleep Apnea Therapy Device in people with Obstructive Sleep Apnea Hypopnea and OSA, run by Ventus Medical, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00772044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2010.