Obstructive Sleep Apnea HypopneaAERO C009ENCT00849043
Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
An observational study of Obstructive Sleep Apnea Hypopnea and Obstructive Sleep Apnea, run by Ventus Medical, Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea, OSAH
- How many people
- 65 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2009to Oct 2010
- Phase
- Observational
- 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
Study population: OSA subjects from C009 AERO study who were randomized to the Provent arm and completed the study. All must continue to meet the C009 inclusion and exclusion criteria.
Who may be able to join
- Based upon scoring at the study site, the 3-month 'device on' PSG has a 50% reduction in AHI compared to the 1-week 'device off' PSG AHI OR the 3-month 'device on' PSG AHI <10
- Used the Provent device at least 4 hours for at least 5/7 nights per week on average during months 1 and 2 of the three month C009 study
- The study physician and investigator believe that continued Provent use does not represent a significant safety risk for the patient
- Patient understands and is willing and able to comply with study requirements
Who cannot join
- 1. The patient must continue to not meet all of the exclusion criteria of protocol C009
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342
Sleep HealthCenters
Brighton, Massachusetts, 02135
St. Luke's Hospital Sleep Medicine & Research Center
Chesterfield, Missouri, 63001
The Corvallis Clinic
Corvallis, Oregon, 97330
Sleep Medicine Associates of Texas
Dallas, Texas, 75231
Wayne State University Harper Univ. Hospital
Detroit, Michigan, 48201
Suburban Lung Associates
Elk Grove Village, Illinois, 60007
University of Florida Health Science Center
Gainesville, Florida, 32610-0225
Borgess Research
Kalamazoo, Michigan, 49024
Kentucky Research Group
Louisville, Kentucky, 40217
Mayo Clinic
Rochester, Minnesota, 55905
Sleep Therapy and Research Center
San Antonio, Texas, 07829
Gaylord Sleep Medicine Research
Wallingford, Connecticut, 06492
About this study
Official title: A Single Arm, Open-label Extension Study to Evaluate the Long-term Durability of Treatment Response and and Safety of the Provent Professional Sleep Apnea Therapy Device for the Non-invasive Treatment of Obstructive Sleep Apnea-hypopnea
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent device.
- Keywords
- obstructive sleep apnea hypopnea, OSA, OSAH
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Provent | Provent Professional Sleep Apnea Therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the percent change in the subject's apnea-hypopnea index (AHI) during the 12 month PSG while wearing the Provent device as compared to their AHI during the first week PSG when the subject did not wear the Provent device in the C009 study
Measured: 12 months
Secondary outcomes (1)
Measurement of the subjects quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2010
- Study completionOct 2010
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
- Observational
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Meir Kryger, MD, Principal investigator, Gaylord Sleep Medicine Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849043
- Sponsor's protocol ID
- AERO C009E
- Acronym
- AERO C009E
- Status last verified
- Jan 2011
- First submitted
- 19 Feb 2009
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kryger MH, Berry RB, Massie CA. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). J Clin Sleep Med. 2011 Oct 15;7(5):449-53B. doi: 10.5664/JCSM.1304.
PubMed 22003339
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-label Extension Study to Evaluate the Long-term Durability of Treatment Response and and Safety of the Provent Professional Sleep Apnea Therapy Device for the Non-invasive Treatment of Obstructive Sleep Apnea-hypopnea
- ClinicalTrials.gov ID
- NCT00849043
- Acronym / sponsor ID
- AERO C009E / AERO C009E
- Keywords
- obstructive sleep apnea hypopnea, OSA, OSAH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Ventus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Feb 2009 (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.
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent device.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Provent | – | –Provent Professional Sleep Apnea Therapy device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OSA subjects from C009 AERO study who were randomized to the Provent arm and completed the study. All must continue to meet the C009 inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Based upon scoring at the study site, the 3-month 'device on' PSG has a 50% reduction in AHI compared to the 1-week 'device off' PSG AHI OR the 3-month 'device on' PSG AHI <10
- Used the Provent device at least 4 hours for at least 5/7 nights per week on average during months 1 and 2 of the three month C009 study
- The study physician and investigator believe that continued Provent use does not represent a significant safety risk for the patient
- Patient understands and is willing and able to comply with study requirements
Key exclusion criteria (1 listed)
- 1. The patient must continue to not meet all of the exclusion criteria of protocol C009
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To measure the percent change in the subject's apnea-hypopnea index (AHI) during the 12 month PSG while wearing the Provent device as compared to their AHI during the first week PSG when the subject did not wear the Provent device in the C009 study
Time frame: 12 months
1 secondary outcome
Measurement of the subjects quality of life
Time frame: 12 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 26 Jan 2011.
- Derived from this study: PubMed 22003339Kryger MH, Berry RB, Massie CA. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). J Clin Sleep Med. 2011 Oct 15;7(5):449-53B. doi: 10.5664/JCSM.1304.
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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.
Meir Kryger, MD principal investigator
Gaylord Sleep Medicine Research
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Hypopnea and Obstructive Sleep Apnea, run by Ventus Medical, Inc. at 13 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 4 inclusion and 1 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 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
To measure the percent change in the subject's apnea-hypopnea index (AHI) during the 12 month PSG while wearing the Provent device as compared to their AHI during the first week PSG when the subject did not wear the Provent device in the C009 study (time frame: 12 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 NCT00849043, 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 26 Jan 2011; AzTrials last refreshed its copy on 30 Oct 2026.