Completed

THN2Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System

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What is being tested

aura6000 THN System

Device
Who is being recruted

Mental Disorders+11

+ Neurologic Manifestations

+ Pathological Conditions, Signs and Symptoms

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorImThera Medical, Inc.
Last updated: August 12, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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).

NCT01796925
Principal SponsorImThera Medical, Inc.
Last updated: August 12, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

57 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersNeurologic ManifestationsPathological Conditions, Signs and SymptomsDyssomniasApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, RespiratorySleep Apnea SyndromesSleep Wake DisordersSleep Apnea, ObstructiveSleep Disorders, Intrinsic

Criteria

4 inclusion criteria required to participate
AHI > 20
Noncompliant to CPAP
Willing to comply with all follow-up visits and evaluations
Willing to provide informed consent
4 exclusion criteria prevent from participating
Anatomic variations interfering with device placement or stability
BMI limits
COPD
Central Sleep Apnea

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Sharp Rees Stealy Medical Center

San Diego, United StatesOpen Sharp Rees Stealy Medical Center in Google Maps

Porter Adventist Hospital

Denver, United States

Chicago ENT

Chicago, United States

Orange Regional Medical Center

Middletown, United States
Completed9 Study Centers