US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

Apnex Medical

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obstructive Sleep Apnea

Treatments: Device: HGNS Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211444

CLP-004

Details and patient eligibility

About

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria

1. Previously diagnosed with moderate-to-severe obstructive sleep apnea.
2. Subject has failed or does not tolerate CPAP treatment.
3. Age between 21 and 70 years.
4. Body mass index (BMI) less than or equal to 37.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

HGNS System

Experimental group

Treatment:

Device: HGNS Treatment