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Completed

NCT Number: NCT01211444

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

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).

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of California San Francisco, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria

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

Treatment and study plan

HGNS Treatment

Device

The Apnex Hypoglossal Nerve Stimulation System (HGNS) is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping and off when the patient is awake.

Primary outcomes

  1. Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline

    Time frame: 6 months post-implant

  2. Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline

    Time frame: 6 months post-implant

  3. The frequency of serious adverse events.

    Time frame: One month post-implant.

  4. The frequency of serious adverse events.

    Time frame: 3 months post-implant.

  5. The frequency of serious adverse events.

    Time frame: 6 months post-implant.

Sponsors and collaborators

Lead sponsor

Apnex Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 29, 2010
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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