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

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.