Targeted Hypoglossal Neurostimulation Study #3 (THN3)

ImThera Medical

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: aura6000 System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02263859

IMT 2014-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Treatment

Experimental group

Description:

The Treatment Group will be implanted with the aura6000 System and have therapy turned ON at the Month 1 follow-up visit.

Treatment:

Device: aura6000 System

Control

Other group

Description:

The Control Group will be implanted with the aura6000 System and receive treatment as-usual, (i.e. any non-PAP, non-surgical OSA treatment including oral appliances and positional devices being used prior to enrollment in the study) until 14 days (washout period) prior to the Month 4 visit. At the Month 4 + 1 day follow-up visit, subjects in the Control Group will have therapy turned ON for the duration of the study.

Treatment:

Device: aura6000 System