Targeted Hypoglossal Neurostimulation Study #2 (THN2)

ImThera Medical

Status: Completed

Conditions: Syndrome, Obstructive Sleep Apnea; Sleep Apnea Syndromes; Respiration Disorders; Sleep Apnea, Obstructive; Signs and Symptoms, Respiratory

Treatments: Device: aura6000 THN System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01796925

IMT2012-02

Details and patient eligibility

About

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).

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

aura6000 THN Therapy

Experimental group

Description:

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

Treatment:

Device: aura6000 THN System