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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obstructive Sleep Apnoea

Intervention / Treatment
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* Device: Rehabilitation device based on electrical stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Electrostimulation begins with electrodes placed on the skin in the submental and submandibular triangles, making sure not to place electrodes on the carotid sinus. The goal of this stimulation will be topographical closeness of the genioglossus, geniohyoid, mylohyoid, platysma and digastric muscles.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assigned Interventions<br>Patients will undergo a conventional flexible nasopharyngeal laryngoscopy in which the degree of obstruction and the laryngopharyngeal sensitivity during wakefulness will be determined. Electrostimulation will be applied at different submandibular points with increasing intensity until the contraction of the dilation muscles of the airway or until the patient cannot tolerate the electrostimulation. The presence of contraction of stimulated muscles will be determined by external and endoscopic inspection. | Device: Rehabilitation device based on electrical stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of the apnoea-hypopnea index (AHI) during sleep | A median reduction of 10 on the AHI is expected with the intervention. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desaturation index | number of desaturations per hour during sleep. | 2 months | 
| sleep time spent under 90% oxygen saturation (T90) | Percentage of sleep time spent under 90% oxygen saturation. | 2 months | 
| oxygen saturation by pulse oximetry (SpO2) nadir | Lowest oxygen saturation by pulse oximetry. | 2 months | 
| Mean SpO2 | Mean oxygen saturation by pulse oximetry. | 2 months | 
| Number of patients who lower one or more categories in the severity of OSA | Moving from severe to moderate, severe to mild or moderate to mild OSA or normalising the AHI | 2 months | 
| Number of patients who climb one or more categories in the severity of OSA | Moving from mild to moderate, mild to severe or moderate to severe OSA | 2 months | 
| Improvement in the Sleep Apnoea Quality of Life Index (SAQLI) | Improvement in the quality of life as measured by the SAQLI | 2 months | 
| Improvement in the Epworth Sleepiness Scale (ESS) | Improvement in daytime sleepiness as measured by the ESS | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation device, Electrical stimulation, Genioglossus muscle, Laryngopharyngeal sensory test