## Protocol Section
### Identification Module
**NCT ID:** NCT06415981

**Brief Title:** Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea

**Official Title:** Single Center Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea

#### Organization Study ID Info
**ID:** IM-003
#### Organization
**Class:** INDUSTRY
**Full Name:** Invicta Medical Inc.
### Status Module
#### Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-12-21

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University College London Hospitals

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Invicta Medical Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.

### Conditions Module

**Conditions:**

- Sleep Apnea

- Sleep Apnea, Obstructive

- Sleep Disorder

- Sleep Apnea Syndromes

**Keywords:**

- Sleep Apnea

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 7

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation

**Label:** Hypoglossal nerve and/or Ansa Cervicalis stimulation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hypoglossal nerve and/or Ansa Cervicalis stimulation

**Description:** Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis

**Name:** Hypoglossal nerve and/or Ansa Cervicalis stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Assessment of patients with changes in acute cross-sectional area airway opening measured in cm2 under nasoendoscopy when stimulating two neural targets (the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures.

**Measure:** Incidence of participants with changes in cross-sectional area airway opening during target stimulation

**Time Frame:** Day 0

**Description:** Assessment of acute changes in airflow when stimulating the HGN in combination with the AC during a flow limited event (hypopnea or apnea).

**Measure:** Assessment of changes in airflow outcomes

**Time Frame:** Day 0

#### Secondary Outcomes

**Description:** To evaluate and report all observed participant adverse events observed during study.

**Measure:** Number of participant adverse events observed during the study

**Time Frame:** Day 30

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age above 18 years not under guardianship, under curatorship or under judicial protection.
* Body Mass Index (BMI) \< 35 kg/m2.
* Subject suffers from OSA (15 \< AHI \< 80) documented by a sleep study performed during the past 36 months.
* Subject must be eligible for a diagnostic or surgical procedure.
* Written informed consent obtained from the patient prior to performing any study specific procedure.
* Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.

Exclusion Criteria:

* Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned
* Significant comorbidities that contraindicate surgery or general anesthesia
* Significant tongue weakness
* Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator.
* Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:
* Airway cancer surgery or radiation,
* Mandible or maxilla surgery in the previous 3 years (not counting dental treatments),
* Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
* Prior hypoglossal nerve stimulation device implantation.
* Currently pregnant, or breastfeeding during the study period

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** London

**Country:** United Kingdom

**Facility:** University College London Hospital

**Zip:** NWI 2PG

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M4361

- Name: Apnea

- Relevance: HIGH

- As Found: Apnea

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: HIGH

- As Found: Sleep Apnea

- ID: M22010

- Name: Sleep Apnea, Obstructive

- Relevance: HIGH

- As Found: Sleep Apnea, Obstructive

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: HIGH

- As Found: Sleep Disorders

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- 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: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001049

- Term: Apnea

- ID: D000012891

- Term: Sleep Apnea Syndromes

- ID: D000020181

- Term: Sleep Apnea, Obstructive

- ID: D000012893

- Term: Sleep Wake Disorders

### Misc Info Module

- Version Holder: 2024-05-31
