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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211444
• Other study ID #: CLP-004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 20, 2010
• Last updated: April 14, 2015
• Start date: July 2010
• Est. completion date: August 2013

Study information

• Verified date: October 2011
• Source: Apnex Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• HGNS Treatment
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.

Locations

Country	Name	City	State
United States	Saint Vincent Hospital	Indianapolis	Indiana
United States	University of Minnesota	Minneapolis	Minnesota
United States	Clinilabs, Inc.	New York	New York
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Apnex Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline		6 months post-implant	No
Primary	Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline		6 months post-implant	No
Primary	The frequency of serious adverse events.		One month post-implant.	Yes
Primary	The frequency of serious adverse events.		3 months post-implant.	Yes
Primary	The frequency of serious adverse events.		6 months post-implant.	Yes

External Links

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