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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Medtronic 8-contact Vectris subcompact or compact electrode.

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge Cuartas Arango, Principal Investigator; Phone Number: 3116004456; Email: jcuartas83@hotmail.com

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 055421
      • Clínica de Otorrinolaringología de Antioquia (ORLANT)
      • Contact: Jorge Cuartas, Principal Investigator; Phone Number: 3116004456; Email: jcuartas83@hotmail.com
      • Principal Investigator: Jorge Cuartas, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index (AHI)	Demonstrate an AHI reduction from baseline of 50% and an AHI less than 20 on follow-up polysomnography	6 months
Oxygen Desaturation Index (ODI)	Demonstrate at least a 25% reduction in the ODI from the initial value.	6 months
Security	The primary safety objective is to assess the incidence of events Adverse events related to the device and the insertion technique	6 months

Collaborators and Investigators

• Sponsor: Capri Medical Limited

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; hypopnea syndrome
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: CAP 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes