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

NCT05914948 | Not Yet Recruiting FDA Device

• 1 other identifier: CAP 001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; hypopnea syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

OTHER

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.

Interventions

Medtronic 8-contact Vectris subcompact or compact electrode. DEVICE

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

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

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>22 and \<75 years
• Moderate or severe apnea (Apnea-Hypopnea Index, AHI, between 1550 per hour and \<25% of central apneas)
• 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.
• 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).
• Patients willing and able to give their informed consent.
• Willing and able to have a pacing system temporarily implanted, and use the patient programmer to activate the stimulation.
• Willing and able to return for all follow-up visits and sleep studies and able to fill out questionnaires.

You may not qualify if:

• Body mass index (BMI) \>32 kg/m.
• Central or mixed apneas \> or = 25%.
• Patients who are pregnant or planning to become pregnant.
• Presence of a complete collapse at the level of the palate corroborated by drug-induced endoscopy (DISE).
• Surgical resection or radiation therapy for cancer or congenital malformations of the larynx, tongue, or throat.
• Significant comorbidities that make the patient unable or inappropriate to participate in the trial.
• Patients with a history of lack of response to electrical stimulation of the hypoglossal nerve.
• Patients with the presence of other implantable electrical devices such as:
• spinal cord stimulator, pacemaker, cochlear implant, peripheral nerve stimulator, etc.

Sponsors & Collaborators

• Capri Medical Limited: lead

Study Sites (1)

Clínica de Otorrinolaringología de Antioquia (ORLANT)

Medellín, Antioquia, 055421, Colombia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Jorge Cuartas Arango, Principal Investigator

CONTACT

3116004456; jcuartas83@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 22, 2023
• Study Start: May 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

CO (1)