Safety and Performance Study of the Nyxoah SAT System for Treating OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

Safety and Performance Study of the Use of the Nyxoah SAT System for the Treatment of Obstructive Sleep Apnea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02312479
• Other study ID #: SAT2014A
• Status: Terminated
• Phase: N/A
• First received: December 4, 2014
• Last updated: September 26, 2016
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Nyxoah S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed with moderate to severe Obstructive Sleep Apnea

• Have failed or have not tolerated CPAP treatment

• Willing and capable of providing informed consent

• Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

Exclusion Criteria:

• BMI limits

• Subjects with complete concentric collapse at the soft palate level per endoscopy

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Nyxoah SAT system
The Nyxoah SAT system is comprised of an implantable nerve stimulator implanted over one of the tongue muscles via a minimally invasive procedure. Stimulation of the Hypoglossal nerves causes the tongue muscles to contract, thus maintaining an open airway during sleep.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem
Germany	Universitäts-HNO-Klinik Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Nyxoah S.A.

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious device related adverse events		6-months post-implantation	Yes
Primary	Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation		6-months post-implantation	No