Clinical trial NCT05914948: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
hypopnea syndrome
Lead sponsor: Capri Medical Limited
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects meeting study eligibility criteria will be implanted with a Medtronic 8-contact Vectris subcompact or compact electrode.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 6 months
measure: Oxygen Desaturation Index (ODI)
timeFrame: 6 months
measure: Security
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Clínica de Otorrinolaringología de Antioquia (ORLANT)
state: Antioquia
Study officials:
References: