Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Australian 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: NCT01186926
• Other study ID #: CLP-003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 20, 2010
• Last updated: April 14, 2015
• Start date: March 2009
• Est. completion date: May 2013

Study information

• Verified date: December 2011
• Source: Apnex Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2013
• Est. primary completion date: December 2010
• 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 40

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 (HGNS) System 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Apnex Medical, Inc.

References & Publications (1)

Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, — View Citation

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	Adverse event profile interoperatively, perioperatively, and long term post implant		1, 3, 6, 12, 24, and 36 months post implant	Yes
Secondary	Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline		6 months post-implant	No

External Links

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