Obstructive Sleep ApneaNCT02180815
REV 002 Observational Study of the ReVENT Sleep Apnea System: Minimally Invasive Treatment for Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Revent Medical International B.V. at 14 sites in 5 countries.
Trial summary
The purpose of this post-market observational study is to assess the effectiveness and patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- ReVENT Sleep Apnea System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Sep 2014to Apr 2017
- 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: Patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure
Who may be able to join
- Patient diagnosed with Obstructive Sleep Apnea due to primary tongue base closure.
- AHI ≥ 10 and AHI ≤ 40 (at least 90% of apneas and hypopneas must be obstructive).
- BMI ≤ 32.
- Confirmation of tongue base closure as the primary source of obstruction with Drug Induced Sleep Endoscopy (DISE).
Who cannot join
- Patient with prior tongue-base surgery
- Uvulopalatopharyngoplasty, soft palate surgery, tonsillectomy or minimally invasive RF ablation of the tongue within the last six (6) months.
- History of mandibular and/or hyoid advancement to treat OSA.
- Any contraindications as listed in the approved Instructions for Use.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Germany7 sites
St Joseph-Stift
Bremen, 28209
St. Franziskus Hospital HNO-Klinik
Cologne, 50825
Alfried Krupp Krankenhaus
Essen, 45131
Asklepios Klinik Harburg
Hamburg, 21075
Universitäts-HNO-Klinik Mannheim
Mannheim, 68135
Klinikum Ernst von Bergmann
Potsdam, 14467
Universitätsklinikum HNO-Klinik
Ulm, 89075
Netherlands3 sites
MC Slotervaart
Amsterdam
Sint Antonius Hospital
Nieuwegein
ISALA Afdeling KNO-Heelkunde Isala
Zwolle
Belgium2 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
University Hospital Antwerp
Edegem
Switzerland1 site
Cantonal Hospital Baselland - ENT Department
Liestal, 4410
About this study
Official title: ReVENT Sleep Apnea System, a Minimally Invasive Approach to Treat Obstructive Sleep Apnea: a Prospective Multicenter Post-Market Observational Study
The purpose of this post-market observational study is to assess the effectiveness and patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep Apnea System consists of an implanter kit and tongue implants. The implants are permanently implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent tongue base closure during sleep.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- ReVENT Sleep Apnea System
- Keywords
- Obstructive Sleep Apnea, Obstructive Sleep Apnea due to primary tongue base closure, Minimally invasive surgery, ReVENT Sleep Apnea System, Tongue implants
- 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.
ReVENT Sleep Apnea SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| ReVENT implanted group | Not described Receives: Device: ReVENT Sleep Apnea System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Apnea-Hypopnea Index (AHI)
Measured: 3, 6 and 12 months
Secondary outcomes (1)
Patient perception of benefit as measured by change in daytime sleepiness and sleep-related quality of life
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Why it stopped: Sufficient follow-up information obtained to support study goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Revent Medical International B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Revent Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Wolfgang Bergler, Principal investigator, St. Joseph-Stift
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180815
- Sponsor's protocol ID
- REV 002
- Status last verified
- Mar 2017
- First submitted
- 11 Jun 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReVENT Sleep Apnea System, a Minimally Invasive Approach to Treat Obstructive Sleep Apnea: a Prospective Multicenter Post-Market Observational Study
- ClinicalTrials.gov ID
- NCT02180815
- Acronym / sponsor ID
- REV 002
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Obstructive Sleep Apnea due to primary tongue base closure, Minimally invasive surgery, ReVENT Sleep Apnea System, Tongue implants
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sufficient follow-up information obtained to support study goals
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Revent Medical International B.V.Industry (pharma, biotech, devices)
- Collaborators
- Revent Medical, Inc.
- Study start
- Sep 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 3 Jul 2014 (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 post-market observational study is to assess the effectiveness and patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep Apnea System consists of an implanter kit and tongue implants. The implants are permanently implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent tongue base closure during sleep.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReVENT implanted group | – | Device: ReVENT Sleep Apnea System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure
Key inclusion criteria (4 listed)
- Patient diagnosed with Obstructive Sleep Apnea due to primary tongue base closure.
- AHI ≥ 10 and AHI ≤ 40 (at least 90% of apneas and hypopneas must be obstructive).
- BMI ≤ 32.
- Confirmation of tongue base closure as the primary source of obstruction with Drug Induced Sleep Endoscopy (DISE).
Key exclusion criteria (4 listed)
- Patient with prior tongue-base surgery
- Uvulopalatopharyngoplasty, soft palate surgery, tonsillectomy or minimally invasive RF ablation of the tongue within the last six (6) months.
- History of mandibular and/or hyoid advancement to treat OSA.
- Any contraindications as listed in the approved Instructions for Use.
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 |
|---|---|---|
| ReVENT Sleep Apnea System | Device | ReVENT implanted group |
Primary outcome
Reduction in Apnea-Hypopnea Index (AHI)
Time frame: 3, 6 and 12 months
1 secondary outcome
Patient perception of benefit as measured by change in daytime sleepiness and sleep-related quality of life
Time frame: 3, 6 and 12 months
Results and safety
The study was stopped early (reason given: Sufficient follow-up information obtained to support study goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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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.
Prof. Dr. Wolfgang Bergler principal investigator
St. Joseph-Stift
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Revent Medical International B.V. at 14 sites in 5 countries.
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 4 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: stopped early, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Netherlands, Belgium, Czechia, Switzerland. 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 was stopped early (reason given: Sufficient follow-up information obtained to support study goals). Results are not available in the source record.
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?
Reduction in Apnea-Hypopnea Index (AHI) (time frame: 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2017.