Obstructive Sleep Apnea Clinical Trial
Official title:
Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05857384 -
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
|
Phase 1 | |
| Recruiting |
NCT04547543 -
Follow-up of Apneic Patients by Visio-consultation
|
N/A | |
| Recruiting |
NCT05371509 -
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
|
N/A | |
| Completed |
NCT02515357 -
Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
|
N/A | |
| Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
| Active, not recruiting |
NCT03189173 -
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|
Phase 2 | |
| Completed |
NCT04084899 -
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
|
||
| Completed |
NCT03032029 -
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
|
||
| Recruiting |
NCT04028011 -
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
|
||
| Recruiting |
NCT06047353 -
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
|
N/A | |
| Completed |
NCT05253963 -
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
|
N/A | |
| Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
| Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
| Completed |
NCT03589417 -
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
|
||
| Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
| Withdrawn |
NCT04063436 -
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
|
N/A | |
| Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
| Recruiting |
NCT04572269 -
Metabolomics of Obstructive Sleep Apnea
|
||
| Not yet recruiting |
NCT06467682 -
12-week Tele-exercise Program in Patients With OSA
|
N/A | |
| Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A |