Overview

This trial is active, not recruiting.

Conditions sleep apnea syndromes, sleep apnea, obstructive, respiration disorders, signs and symptoms, respiratory, syndrome, obstructive sleep apnea
Treatment aura6000 thn system
Phase phase 2/phase 3
Sponsor ImThera Medical, Inc.
Start date February 2013
End date September 2013
Trial size 60 participants
Trial identifier NCT01796925, IMT2012-02

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The aura6000 THN system will be implanted and activated for nightly therapy during sleep.
aura6000 thn 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.

Primary Outcomes

Measure
Reduction in Apnea-Hypopnea Index (AHI)
time frame: 3, 6, and 12 months post implant
Reduction in Oxygen Desaturation Index (ODI)
time frame: 3, 6, and 12 months post implant
Freedom from Serious Adverse Events (SAE)
time frame: 1 and 12 months post implant

Secondary Outcomes

Measure
Improvement in sleep fragmentation
time frame: 3, 6, and 12 months post-implant
Improvement in SAQLI
time frame: 3, 6, and 12 months post implant
Improvement in ESS
time frame: 3, 6, and 12 months post implant

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - AHI >20 - Noncompliant to CPAP - Willing to provide informed consent - Willing to comply with all follow-up visits and evaluations Exclusion Criteria: - BMI limits - COPD - Central Sleep Apnea - Anatomic variations interfering with device placement or stability.

Additional Information

Official title Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System
Principal investigator Daniel Rodenstein, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by ImThera Medical, Inc..