## Protocol Section
### Identification Module
**NCT ID:** NCT02312479

**Brief Title:** Safety and Performance Study of the Nyxoah SAT System for Treating OSA

**Official Title:** Safety and Performance Study of the Use of the Nyxoah SAT System for the Treatment of Obstructive Sleep Apnea

#### Organization Study ID Info
**ID:** SAT2014A
#### Organization
**Class:** INDUSTRY
**Full Name:** Nyxoah S.A.
### Status Module
#### Completion Date
**Date:** 2016-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-09-27

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-09-26

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2015-11

**Type:** ACTUAL

#### Start Date
**Date:** 2014-12

**Status Verified Date:** 2016-09

#### Study First Post Date
**Date:** 2014-12-09
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-04
**Study First Submit QC Date:** 2014-12-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Nyxoah S.A.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief 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

### Conditions Module

**Conditions:**

- Obstructive Sleep Apnea

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 6

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Nyxoah SAT system

**Label:** Nyxoah SAT therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Nyxoah SAT therapy

**Description:** 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.

**Name:** Nyxoah SAT system

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of serious device related adverse events

**Time Frame:** 6-months post-implantation

**Measure:** Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation

**Time Frame:** 6-months post-implantation

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 70 Years

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Edegem

**Country:** Belgium

**Facility:** Antwerp University Hospital

**Location 2:**

**City:** Mannheim

**Country:** Germany

**Facility:** Universitäts-HNO-Klinik Mannheim

#### Overall Officials

**Official 1:**

**Affiliation:** Universitäts-HNO-Klinik Mannheim

**Name:** Joachim T Maurer, OA Dr. med.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Universiteit Antwerpen

**Name:** Evert Hamans, PhD Dr.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001049

- Term: Apnea

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M4361

- Name: Apnea

- Relevance: LOW

- As Found: Unknown

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: HIGH

- As Found: Sleep Apnea

- ID: M22010

- Name: Sleep Apnea, Obstructive

- Relevance: HIGH

- As Found: Obstructive Sleep Apnea

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012891

- Term: Sleep Apnea Syndromes

- ID: D000020181

- Term: Sleep Apnea, Obstructive

### Misc Info Module

- Version Holder: 2024-05-24
