Targeted Hypoglossal Neurostimulation Study #3

Obstructive Sleep Apnea Clinical Trial

— THN3  

Official title:

ImThera Medical Targeted Hypoglossal Neurostimulation Study #3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263859
• Other study ID #: IMT 2014-01
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2024
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.

Description:

The objectives of this study are to evaluate the safety and effectiveness of the aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances, positional devices and conventional sleep surgeries). PAP failure is defined as an inability to eliminate OSA (AHI > 20 despite PAP usage) and PAP intolerance is defined as: 1) inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it). The results of this study are anticipated to provide reasonable assurance of the safety and effectiveness of the aura6000 System when used as intended and to support the application for FDA Premarket Approval of the system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 1, 2023
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Individual has failed or does not tolerate PAP therapy

• Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and behavioral treatments)

• AHI = 20 (Moderate to severe OSA)

Exclusion Critera:

• Implanted with another active implantable device

• Body mass index (BMI) = 35 kg/m²

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• aura6000 System
The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).

Locations

Country	Name	City	State
Belgium	Clinique Univ. Saint-Luc	Brussels
France	Pitie Salpetriere	Paris
France	Foch Hospital	Suresnes
Germany	Ruprechts-Karls University	Mannheim
Israel	Bnai Zion Medical Center	Haifa
Portugal	Hospital CUF Porto	Porto
United States	Advanced ENT Asociates	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	Johns Hopkins University	Baltimore	Maryland
United States	Ear, Nose, and Throat Associates of South Florida	Boca Raton	Florida
United States	Center for ENT and Allergy	Carmel	Indiana
United States	Medical University of South Carolina	Charleston	South Carolina
United States	ENT Associates of San Diego	Chula Vista	California
United States	Intrepid Research	Cincinnati	Ohio
United States	Tower ENT	Los Angeles	California
United States	Kentucky Research Group	Louisville	Kentucky
United States	UT Methodist Physicians	Memphis	Tennessee
United States	ENT and Allergy Associates	New York	New York
United States	Morton Plant Mease Healthcare	Safety Harbor	Florida
United States	SENTA Clinic	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
ImThera Medical, Inc.	LivaNova

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Israel,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Apnea Hypopnea Index (AHI)	Proportion of subjects who experience improvement in the apnea-hypopnea index (AHI) at the Month 4 visit as defined above in the AHI Responder definition.; It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.	Baseline to 4 months post-implant
Primary	Improvement in Oxygen Desaturation Index (ODI)	Proportion of subjects who experience improvement in the oxygen desaturation index 4% (ODI 4%) at the Month 4 visit as defined above in the ODI Responder definition.; It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.	Baseline to 4 months post-implant
Primary	Safety Analysis	Estimate the incidence of serious adverse events (SAEs) related to the aura6000 device or procedure, including any unanticipated adverse device effects.	Baseline to 12 months post-implant
Secondary	Long-term Responder Rate		Baseline to 12 months post-implant
Secondary	Change in Epworth Sleepiness Scale (ESS)		Baseline to 4 months post-implant
Secondary	Change in Functional Outcomes of Sleep (FOSQ)		Baseline to 4 months post-implant
Secondary	Change in EuroQol 5 Dimensional (EQ-5D)		Baseline to 4 months post-implant