Clinical Trial of a Rehabilitation Device Based on Electrical Stimulation for Patients With Obstructive Sleep Apnoea (OSA): a Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Improvement of the apnoea-hypopnea index (AHI) during sleep
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Assigned Interventions
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.
干预措施: Rehabilitation device based on electrical stimulation (Device)
结局指标
主要结局
Improvement of the apnoea-hypopnea index (AHI) during sleep
时间窗: 2 months
A median reduction of 10 on the AHI is expected with the intervention.
次要结局
- Mean SpO2(2 months)
- Improvement in the Sleep Apnoea Quality of Life Index (SAQLI)(2 months)
- Number of patients who lower one or more categories in the severity of OSA(2 months)
- oxygen saturation by pulse oximetry (SpO2) nadir(2 months)
- sleep time spent under 90% oxygen saturation (T90)(2 months)
- Desaturation index(2 months)
- Number of patients who climb one or more categories in the severity of OSA(2 months)
- Improvement in the Epworth Sleepiness Scale (ESS)(2 months)
研究者
Luis F. Giraldo-Cadavid
MD, PhD. Pulmonary Medicine, Interventional Pulmonology
Fundación Neumologica Colombiana