NCT02180815

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
5 countries

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

2.6 years

First QC Date

June 11, 2014

Last Update Submit

March 30, 2017

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaObstructive Sleep Apnea due to primary tongue base closureMinimally invasive surgeryReVENT Sleep Apnea SystemTongue implants

Outcome Measures

Primary Outcomes (1)

  • Reduction in Apnea-Hypopnea Index (AHI)

    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

    3, 6 and 12 months

Other Outcomes (1)

  • Safety profile assessed by incidence of adverse events

    1 week, 6 and 12 months

Study Arms (1)

ReVENT implanted group

Device: ReVENT Sleep Apnea System

Interventions

ReVENT Sleep Apnea SystemDEVICE
ReVENT implanted group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

University Hospital Antwerp

Edegem, Belgium

Location

Pavelec LENTE, Ltd.

Pilsen, 30101, Czechia

Location

St Joseph-Stift

Bremen, 28209, Germany

Location

St. Franziskus Hospital HNO-Klinik

Cologne, 50825, Germany

Location

Alfried Krupp Krankenhaus

Essen, 45131, Germany

Location

Asklepios Klinik Harburg

Hamburg, 21075, Germany

Location

Universitäts-HNO-Klinik Mannheim

Mannheim, 68135, Germany

Location

Klinikum Ernst von Bergmann

Potsdam, 14467, Germany

Location

Universitätsklinikum HNO-Klinik

Ulm, 89075, Germany

Location

MC Slotervaart

Amsterdam, Netherlands

Location

Sint Antonius Hospital

Nieuwegein, Netherlands

Location

ISALA Afdeling KNO-Heelkunde Isala

Zwolle, Netherlands

Location

Cantonal Hospital Baselland - ENT Department

Liestal, 4410, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Prof. Dr. Wolfgang Bergler

    St. Joseph-Stift

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2014

First Posted

July 3, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CZ(1)CH(1)NL(3)BE(2)DE(7)