Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

ImThera Medical

Status: Completed

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

Treatments: Device: aura6000 System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01532180

IMT 2009-01/02/03

Details and patient eligibility

About

The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Enrollment: 14 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Moderate to severe obstructive sleep apnea (AHI 15 to 60).
• Cannot or will not tolerate CPAP treatment.
• Body mass index (BMI) between 25 and 40
• Able to read, understand, sign and date the written informed consent form

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

THN Therapy

Experimental group

Treatment:

Device: aura6000 System