Australian Clinical Study of the Apnex Medical 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

NCT01186926

CLP-003

Details and patient eligibility

About

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).

Enrollment: 40 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 40

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

HGNS Treatment

Experimental group

Treatment:

Device: HGNS Treatment