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SUSPENDED

NCT04607343

Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea

Sponsor: Fundación Neumologica Colombiana

View on ClinicalTrials.gov

Summary

The aim of this study is to evaluate in a clinical trial a rehabilitation device for patients with obstructive sleep apnoea (OSA) based on oropharyngeal electrical stimulation, which strengthens the dilating muscles of the upper airway, improves mechanical laryngopharyngeal sensitivity and improves OSA. Furthermore, to perform experimental electrotherapy, nasoendoscopy, polygraphy and polysomnography tests with the device in order to calculate thresholds of functional and sensory intensities on the dilating muscles of the upper airway in patients with OSA. These tests also include the detection of signals that measure breathing events during sleep in patients with OSA in order to use them in the control mechanisms of the electrostimulation device. Assess the effects and safety of the device in a group of five healthy volunteers for preliminary results. Finally, to evaluate in a small group of patients with OSA the device capacity to stimulate the upper-airway dilating muscles and to reduce the Apnea-Hypopnea Index (AHI) and oxygen desaturation indices when the electrostimulation device is used over a medium-term period (eight weeks) with morning and evening therapy sessions.

Official title: Clinical Trial of a Rehabilitation Device Based on Electrical Stimulation for Patients With Obstructive Sleep Apnoea (OSA): a Study Protocol

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-01

Completion Date

2027-07-01

Last Updated

2026-04-13

Healthy Volunteers

Yes

Conditions

Obstructive Sleep Apnoea

Interventions

DEVICE

Rehabilitation device based on electrical stimulation

Experimental tests with transcutaneous electrical stimulation at different intensities and at the points of the submandibular region previously explored will be conducted first of all on the five healthy volunteer subjects. During these tests, the neuromuscular thresholds of the upper airway, the most effective points of electrostimulation and the tolerance of intervention will be determined. The determination of the functional threshold will be made by clinical evaluation of the subject during stimulation.

Inclusion Criteria: * Patients over 18 years of age with confirmed OSA (four with mild OSA, four with moderate OSA and four with severe OSA) who sign their informed consent to participate in the study. Exclusion Criteria: * Pregnancy * Basal polysomnography that does not meet validity criteria to be interpreted. * Anticoagulation (although not a contraindication for laryngopharyngeal sensory endoscopic testing, anticoagulation is an exclusion criterion for this study to maintain the lowest level of risk). * Haemorrhagic diathesis (to avoid risk of severe epistaxis during nasal endoscopy). * Glasgow scale less than 15 (to avoid confusion with sensory or motor laryngopharyngeal involvement due to neurological disease that compromises the state of consciousness). * Basal oxygen saturation by awake pulse oximetry below 88%. * Patients with more than 5% of the total apnoea events being of central origin. (to avoid including patients with central sleep apnoea in whom laryngopharyngeal electrostimulation would have no effect). * Inflammatory or infectious lesions on the face or neck * Skin hypersensitivity * Anaesthetic areas, burns, bruises or recent wounds in the area of electrical stimulation * Cardiac pacemakers or other telemetry-controlled devices, * History of maxillofacial or pharyngeal surgery. * Active cancer * Tumours of the laryngopharyngeal tract. * Significant mental and/or behavioural conditions or inability of the patient to cooperate during the examination/intervention. * Epilepsy * Central Nervous System (CNS) surgery in the last three months (to avoid confusion with muscle or sensory laryngopharyngeal compromise). * Brain trauma in the last three months (to avoid confusion with muscle or sensory laryngopharyngeal compromise). * Neurological sequelae of any cause compromising the head and neck muscles (to avoid confusion with muscle or sensory laryngopharyngeal compromise). * Underlying neuromuscular diseases affecting the head and neck muscles (to avoid confusion with muscle or sensory laryngopharyngeal involvement due to neuromuscular disease). * Chronic use of systemic corticosteroids at doses greater than or equal to 20 mg daily of prednisone or equivalent (to avoid confusion with corticosteroid myopathy that compromises the laryngopharyngeal region). * Bone prostheses or osteosynthesis (in polarized currents there is danger of chemical burn and bone resorption) * Acute febrile processes * Chronic decompensated diseases * Diseases in terminal states * Refusal to participate in the study.

Locations (2)

Fundacion Neumologica Colombiana

Bogotá, Bogota D.C., Colombia

Universidad de La Sabana

Chía, Cundinamarca, Colombia