Targeted Hypoglossal Neurostimulation Study #2

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome, Obstructive Sleep Apnea; Respiration Disorders; Signs and Symptoms, Respiratory
• Interventions: Device: aura6000 THN System

• Registration Number: NCT01796925
• Lead Sponsor: ImThera Medical, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Primary Completion: 2013-09
• Study Completion: 2014-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aura6000 THN Therapy	aura6000 THN System	The aura6000 THN system will be implanted and activated for nightly therapy during sleep.

Primary Outcome Measures

Name	Time	Method
Reduction in Oxygen Desaturation Index (ODI)	3, 6, and 12 months post implant	Change from baseline in ODI measured through in-lab polysomnography (PSG).
Reduction in Apnea-Hypopnea Index (AHI)	3, 6, and 12 months post implant	Change from baseline in AHI measured through in-lab polysomnography (PSG).
Freedom from Serious Adverse Events (SAE)	1 and 12 months post implant	Adverse events and Serious Adverse events post-operatively

Secondary Outcome Measures

Name	Time	Method
Improvement in ESS	3, 6, and 12 months post implant	Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline.
Improvement in sleep fragmentation	3, 6, and 12 months post-implant	Mean change in microarousal index as compared to baseline.
Improvement in SAQLI	3, 6, and 12 months post implant	Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline.

Trial Locations

Locations (9)

St. Joseph-Stift; 🇩🇪 Bremen, Germany

G.B. Morgagni- L. Pierantoni Hospital; 🇮🇹 Forli, Italy

Advanced Sleep Research; 🇩🇪 Berlin, Germany

Chicago ENT; 🇺🇸 Chicago, Illinois, United States

Sharp Rees Stealy Medical Center; 🇺🇸 San Diego, California, United States

Clinique Univ. Saint-Luc; 🇧🇪 Brussels, Belgium

Pitié-Salpêtrière Hospital; 🇫🇷 Paris, France

Porter Adventist Hospital; 🇺🇸 Denver, Colorado, United States

Orange Regional Medical Center; 🇺🇸 Middletown, New York, United States