Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea
Megadott ok: Lack of resourses and regulatory agency approval
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
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A vizsgálat adatai
- Ki végzi
- Fundación Neumologica Colombiana
- Azonosító
- NCT04607343
- A regiszteradat frissítve
- 2026. április 13.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Clinical Trial of a Rehabilitation Device Based on Electrical Stimulation for Patients With Obstructive Sleep Apnoea (OSA): a Study Protocol
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.
Bevonási feltételek: 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.
Kizáró feltételek: Central Nervous System (CNS) surgery in the last three months (to avoid confusion with muscle or sensory laryngopharyngeal compromise); 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); Glasgow scale less than 15 (to avoid confusion with sensory or motor laryngopharyngeal involvement due to neurological disease that compromises the state of consciousness); Skin hypersensitivity; Cardiac pacemakers or other telemetry-controlled devices,; History of maxillofacial or pharyngeal surgery; Active cancer; Significant mental and/or behavioural conditions or inability of the patient to cooperate during the examination/intervention; Epilepsy; Underlying neuromuscular diseases affecting the head and neck muscles (to avoid confusion with muscle or sensory laryngopharyngeal involvement due to neuromuscular disease); Chronic decompensated diseases; Diseases in terminal states; 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); 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; Anaesthetic areas, burns, bruises or recent wounds in the area of electrical stimulation; Tumours of the laryngopharyngeal tract; 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); Bone prostheses or osteosynthesis (in polarized currents there is danger of chemical burn and bone resorption); Acute febrile processes; Refusal to participate in the study.