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

Primary Purpose

Obstructive Sleep Apnea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Medtronic 8-contact Vectris subcompact or compact electrode.
Sponsored by
Capri Medical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, hypopnea syndrome

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Clínica de Otorrinolaringología de Antioquia (ORLANT)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 9, 2023
Last Updated
June 20, 2023
Sponsor
Capri Medical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05914948
Brief Title
Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea.
Official Title
Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Capri Medical Limited

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, hypopnea syndrome

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
Arm Type
Other
Arm Description
Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
Intervention Type
Device
Intervention Name(s)
Medtronic 8-contact Vectris subcompact or compact electrode.
Intervention Description
Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index (AHI)
Description
Demonstrate an AHI reduction from baseline of 50% and an AHI less than 20 on follow-up polysomnography
Time Frame
6 months
Title
Oxygen Desaturation Index (ODI)
Description
Demonstrate at least a 25% reduction in the ODI from the initial value.
Time Frame
6 months
Title
Security
Description
The primary safety objective is to assess the incidence of events Adverse events related to the device and the insertion technique
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Cuartas Arango, Principal Investigator
Phone
3116004456
Email
jcuartas83@hotmail.com
Facility Information:
Facility Name
Clínica de Otorrinolaringología de Antioquia (ORLANT)
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
055421
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Cuartas, Principal Investigator
Phone
3116004456
Email
jcuartas83@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jorge Cuartas, Dr

12. IPD Sharing Statement

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

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