Clinical trial NCT02180815: REV 002 Observational Study of the ReVENT Sleep Apnea System: Minimally Invasive Treatment for Obstructive Sleep Apnea
Official title: ReVENT Sleep Apnea System, a Minimally Invasive Approach to Treat Obstructive Sleep Apnea: a Prospective Multicenter Post-Market Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Revent Medical International B.V.
Sponsor class: INDUSTRY
Collaborators: name: Revent Medical, Inc.
First posted: 2014-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Reduction in Apnea-Hypopnea Index (AHI)
timeFrame: 3, 6 and 12 months
Secondary outcomes:
measure: Patient perception of benefit as measured by change in daytime sleepiness and sleep-related quality of life
timeFrame: 3, 6 and 12 months
Other outcomes:
measure: Safety profile assessed by incidence of adverse events
timeFrame: 1 week, 6 and 12 months
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Plzeň
country: Czech Republic
facility: Pavelec LENTE, Ltd.
city: Bremen
country: Germany
facility: St Joseph-Stift
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Köln
country: Germany
facility: St. Franziskus Hospital HNO-Klinik
city: Mannheim
country: Germany
facility: Universitäts-HNO-Klinik Mannheim
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
city: Ulm
country: Germany
facility: Universitätsklinikum HNO-Klinik
city: Amsterdam
country: Netherlands
facility: MC Slotervaart
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Hospital
city: Zwolle
country: Netherlands
facility: ISALA Afdeling KNO-Heelkunde Isala
city: Liestal
country: Switzerland
facility: Cantonal Hospital Baselland - ENT Department
Study officials:
affiliation: St. Joseph-Stift
name: Prof. Dr. Wolfgang Bergler
role: PRINCIPAL_INVESTIGATOR
References: