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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Targeted Hypoglossal Neurostimulation Study #2

NCT01796925

Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders +2 more

COMPLETED NA

Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

NCT04950894

Obstructive Sleep Apnea OSA Apnea +4 more

ACTIVE_NOT_RECRUITING NA

Targeted Hypoglossal Neurostimulation Study #3

NCT02263859

Obstructive Sleep Apnea

COMPLETED NA

Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry

NCT06332404

Obstructive Sleep Apnea Sleep Apnea Apnea

RECRUITING

Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve

NCT03844295

Obstructive Sleep Apnea Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

THN Therapy

Group Type EXPERIMENTAL

aura6000 System

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No