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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05914948
• Other study ID #: CAP 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Capri Medical Limited
• Contact: Jorge Cuartas Arango, Principal Investigator
• Phone: 3116004456
• Email: jcuartas83[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Colombia	Clínica de Otorrinolaringología de Antioquia (ORLANT)	Medellín	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Capri Medical Limited

Country where clinical trial is conducted

Colombia, 

Outcome

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