Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

Sleep Apnea, Obstructive Clinical Trial

Official title:

A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532180
• Other study ID #: IMT 2009-01/02/03
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2019
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Moderate to severe obstructive sleep apnea (AHI 15 to 60).

• Cannot or will not tolerate CPAP treatment.

• Body mass index (BMI) between 25 and 40

• Able to read, understand, sign and date the written informed consent form

Related Conditions & MeSH terms

• Apnea
• Respiration Disorders
• Signs and Symptoms
• Signs and Symptoms, Respiratory
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome
• Syndrome, Obstructive Sleep Apnea

Intervention

Device:
• aura6000 System
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.

Locations

Country	Name	City	State
Belgium	Clinique Univ. Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
ImThera Medical, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.		3 and 12 months post-implant
Primary	Adverse events and Serious Adverse events peri and post-operatively		3 and 12 months post-operative
Secondary	Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.		3 and 12 months post-operative
Secondary	Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.		3 and 12 months post-implantation