Lack of resourses and regulatory agency approval

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.

Obstructive sleep apnoea-hypopnoea syndrome (OSA) is a respiratory disorder characterised by repetitive obstruction of the upper airway, leading to several interruptions during sleep. It is currently one of the main public health problems worldwide and one of the main cardiovascular risk factors in developed and intermediate developing countries, whose populations are increasing in obesity and age.

One of the common treatments for OSA is continuous positive airway pressure (CPAP) devices, which pumps air through a hose, reaches a mask that the patient has over his or her nose and travels the airway, keeping the upper airway open during sleep and avoiding episodes of airway collapse. The problem is that CPAP is not accepted by some patients due to a lack of adaptation, so alternative treatments may be needed. For some years, there have been explorations of treatments related to electrical stimulation of the muscles of the upper airway as therapy to reduce the number of episodes of apnoea (measured through the apnoea-hypopnoea index) during the night, strengthening these muscles through stimulation.

This is the protocol of a clinical study of a rehabilitation device for home use that not only provides functional stimulation of the upper-airway dilator muscles but also provides sensory stimulation. This device works by strengthening the dilating muscles of the upper respiratory tract and improving the sensory capacity of the laryngo-pharyngeal tract and is based on existing publications on the effectiveness of functional and somatosensory neurostimulation through neuroplasticity in the recovery of neurological deficits.

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.

The patients clinical data will be entered into an anonymized database hosted on RedCap platform