Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea

NCT ID: NCT05914948

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2025-05-31

Brief Summary

Minimally invasive electrical stimulation of the nerve hypoglossal for the treatment of obstructive sleep apnea.

To demonstrate the correct stimulation of the medial branches of the hypoglossal nerve and tongue protrusion using a minimally invasive implantation technique in patients with OSA.

Detailed Description

Study title: Minimally invasive electrical stimulation of the nerve hypoglossal for treatment for obstructive sleep apnea.

Study device: Medtronic 8-contact Vectris subcompact or compact electrode.

Study design: This is an initial feasibility study that seeks to determine the safety and effectiveness of a minimally invasive technique to implant a hypoglossal nerve stimulation electrode in patients with obstructive sleep apnea.

Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.

In the follow-up visits, quality of life and sleepiness scales (Epworth) will be performed, and on days 4 and 7 a control polysomnography. All results will be compared with the baseline data obtained at the start of the study.

Study Size: Up to 30 subjects may be enrolled to achieve a number of implanted subjects between 10 to 20.

Study Duration: Total expected duration per subject is approximately 10 days. The study is estimated to take 6 months.

Objective of the study: The main objective is to evaluate the safety and effectiveness of a minimally invasive technique to implant a hypoglossal nerve stimulation electrode in patients with obstructive sleep apnea.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Subjects implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.

Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.

Group Type: OTHER

Medtronic 8-contact Vectris subcompact or compact electrode.

Intervention Type: DEVICE

Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.

Interventions

Medtronic 8-contact Vectris subcompact or compact electrode.

Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age >22 and <75 years

2. Moderate or severe apnea (Apnea-Hypopnea Index, AHI, between 1550 per hour and <25% of central apneas)

3. Failure of continuous positive airway pressure (CPAP) therapy defined as the inability to eliminate obstructive sleep apnea and hypopnea syndrome (OSAHS) corresponding to an AHI greater than 20/h despite the use of CPAP.

4. No tolerance to CPAP:

to. Inability to use CPAP (more than 5 nights a week; more than 4 hours a night).

b. Unwillingness to use CPAP (for example, a patient returns the CPAP system after trying to use it).

5. Patients willing and able to give their informed consent.

6. Willing and able to have a pacing system temporarily implanted, and use the patient programmer to activate the stimulation.

7. Willing and able to return for all follow-up visits and sleep studies and able to fill out questionnaires.

Exclusion Criteria

1. Body mass index (BMI) >32 kg/m.

2. Central or mixed apneas > or = 25%.

3. Patients who are pregnant or planning to become pregnant.

4. Presence of a complete collapse at the level of the palate corroborated by drug-induced endoscopy (DISE).

5. Surgical resection or radiation therapy for cancer or congenital malformations of the larynx, tongue, or throat.

6. Significant comorbidities that make the patient unable or inappropriate to participate in the trial.

7. Patients with a history of lack of response to electrical stimulation of the hypoglossal nerve.

8. Patients with the presence of other implantable electrical devices such as:

spinal cord stimulator, pacemaker, cochlear implant, peripheral nerve stimulator, etc.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capri Medical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clínica de Otorrinolaringología de Antioquia (ORLANT)

Medellín, Antioquia, Colombia

Countries

Colombia

Central Contacts

Jorge Cuartas Arango, Principal Investigator

Role: CONTACT

jcuartas83@hotmail.com

3116004456

Facility Contacts

Jorge Cuartas, Principal Investigator

Role: primary

jcuartas83@hotmail.com

3116004456

Other Identifiers

CAP 001

Identifier Type: -

Identifier Source: org_study_id