Obstructive Sleep ApneaNCT05914948
Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea
A study testing Medtronic 8-contact Vectris subcompact or compact electrode. in people with Obstructive Sleep Apnea, run by Capri Medical Limited at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Medtronic 8-contact Vectris subcompact or compact electrode.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteColombia
- Study dates
- May 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Unwillingness to use CPAP (for example, a patient returns the CPAP system after trying to use it).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Clínica de Otorrinolaringología de Antioquia (ORLANT)
Medellín, Antioquia, 055421
Jorge Cuartas, Principal Investigator, 3116004456, jcuartas83@hotmail.com
Jorge Cuartas, Dr
About this study
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.
Read the 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
- Being tested
- Medtronic 8-contact Vectris subcompact or compact electrode.
- Keywords
- Obstructive sleep apnea, hypopnea syndrome
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Medtronic 8-contact Vectris subcompact or compact electrode. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
Demonstrate an AHI reduction from baseline of 50% and an AHI less than 20 on follow-up polysomnography
Measured: 6 months
Oxygen Desaturation Index (ODI)
Demonstrate at least a 25% reduction in the ODI from the initial value.
Measured: 6 months
Security
The primary safety objective is to assess the incidence of events Adverse events related to the device and the insertion technique
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startMay 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capri Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914948
- Sponsor's protocol ID
- CAP 001
- Status last verified
- Feb 2024
- First submitted
- 9 Jun 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05914948
- Acronym / sponsor ID
- CAP 001
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, hypopnea syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Capri Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
| Arm | Type | Receives |
|---|---|---|
| Subjects implanted with a Medtronic 8-contact Vectris subcompact or compact electrode. | Other | 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. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Subjects implanted with a Medtronic 8-contact Vectris subcompact or compact electrode. |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: 6 months
Demonstrate an AHI reduction from baseline of 50% and an AHI less than 20 on follow-up polysomnography
Oxygen Desaturation Index (ODI)
Time frame: 6 months
Demonstrate at least a 25% reduction in the ODI from the initial value.
Security
Time frame: 6 months
The primary safety objective is to assess the incidence of events Adverse events related to the device and the insertion technique
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic 8-contact Vectris subcompact or compact electrode. in people with Obstructive Sleep Apnea, run by Capri Medical Limited at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Cuartas Arango, Principal Investigator (3116004456, jcuartas83@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.