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

Apnex Medical

Status and phase: Terminated; Phase 3

Conditions: Obstructive Sleep Apnea

Treatments: Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )

Study type: Interventional

Funder types: Industry

Identifiers

NCT01446601

IDE #G090014 (Other Identifier)

CLP-005

Details and patient eligibility

About

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.

Enrollment: 132 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age 21 to 80 years
• Body mass index (BMI) ≤ 35 kg/m²
• Previously diagnosed with Moderate to severe OSA
• Individual has failed or does not tolerate PAP therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

Treatment

Experimental group

Description:

The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant.

Treatment:

Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )

Control

Other group

Description:

The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.

Treatment:

Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )