NCT01796925

Brief Summary

The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Trial Health

93
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
5 countries

9 active sites

Status
completed

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

Study Start

First participant enrolled

February 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

February 14, 2013

Last Update Submit

August 8, 2019

Conditions

Sleep Apnea SyndromesSleep Apnea, ObstructiveRespiration DisordersSigns and Symptoms, RespiratorySyndrome, Obstructive Sleep Apnea

Keywords

ApneaRespiration DisordersSigns and SymptomsSigns and Symptoms, RespiratorySleep Apnea SyndromesSleep Apnea, ObstructiveRespiratory Tract DiseasesSleep Disorders, IntrinsicSleep DisordersNervous System Diseases

Outcome Measures

Primary Outcomes (3)

  • Reduction in Apnea-Hypopnea Index (AHI)

    Change from baseline in AHI measured through in-lab polysomnography (PSG).

    3, 6, and 12 months post implant

  • Reduction in Oxygen Desaturation Index (ODI)

    Change from baseline in ODI measured through in-lab polysomnography (PSG).

    3, 6, and 12 months post implant

  • Freedom from Serious Adverse Events (SAE)

    Adverse events and Serious Adverse events post-operatively

    1 and 12 months post implant

Secondary Outcomes (3)

  • Improvement in sleep fragmentation

    3, 6, and 12 months post-implant

  • Improvement in SAQLI

    3, 6, and 12 months post implant

  • Improvement in ESS

    3, 6, and 12 months post implant

Study Arms (1)

aura6000 THN Therapy

EXPERIMENTAL

The aura6000 THN system will be implanted and activated for nightly therapy during sleep.

Device: aura6000 THN System

Interventions

aura6000 THN SystemDEVICE

The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.

aura6000 THN Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AHI \>20
  • Noncompliant to CPAP
  • Willing to provide informed consent
  • Willing to comply with all follow-up visits and evaluations

You may not qualify if:

  • BMI limits
  • COPD
  • Central Sleep Apnea
  • Anatomic variations interfering with device placement or stability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Sharp Rees Stealy Medical Center

San Diego, California, 92123, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Chicago ENT

Chicago, Illinois, 60657, United States

Location

Orange Regional Medical Center

Middletown, New York, 10940, United States

Location

Clinique Univ. Saint-Luc

Brussels, 1200, Belgium

Location

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

Advanced Sleep Research

Berlin, 10117, Germany

Location

St. Joseph-Stift

Bremen, 28209, Germany

Location

G.B. Morgagni- L. Pierantoni Hospital

Forlì, 47121, Italy

Location

Related Publications (2)

  • Zaidi FN, Meadows P, Jacobowitz O, Davidson TM. Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea. Neuromodulation. 2013 Jul-Aug;16(4):376-86; discussion 386. doi: 10.1111/j.1525-1403.2012.00514.x. Epub 2012 Aug 31.

    PMID: 22938390BACKGROUND

  • Mwenge GB, Rombaux P, Dury M, Lengele B, Rodenstein D. Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J. 2013 Feb;41(2):360-7. doi: 10.1183/09031936.00042412. Epub 2012 May 17.

    PMID: 22599356BACKGROUND

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, ObstructiveRespiration DisordersSigns and Symptoms, RespiratoryApneaSigns and SymptomsRespiratory Tract DiseasesSleep Disorders, IntrinsicSleep Wake DisordersNervous System Diseases

Condition Hierarchy (Ancestors)

DyssomniasPathological Conditions, Signs and SymptomsMental DisordersNeurologic Manifestations

Study Officials

  • Daniel Rodenstein, MD, PhD

    Clinique Univ. Saint-Luc

    PRINCIPAL INVESTIGATOR

  • Ofer Jacobowitz, MD PhD

    Hudson Valley ENT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 22, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2014

Last Updated

August 12, 2019

Record last verified: 2019-08

Locations

US(4)DE(2)FR(1)IT(1)BE(1)