Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea.
Obstructive Sleep Apnea
About this trial
This is an interventional device feasibility trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, hypopnea syndrome
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.
Sites / Locations
- Clínica de Otorrinolaringología de Antioquia (ORLANT)
Arms of the Study
Arm 1
Other
Subjects implanted with a 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.