PErsonalized and Adaptive Kinesthetic stImulation Therapy, Based on Cardio-respiratory Holter moNitoring, for Sleep Apnea syndrOmes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LivaNova
- 入组人数
- 42
- 试验地点
- 7
- 主要终点
- Rate of responder to the therapy
研究概览
简要总结
This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.
详细描述
Severe sleep apnea patients will undergo two polysomnographies (PSG), one with kinesthetic stimulation triggered on the detection of apneas and hypopneas (treated night ) and the other without kinesthetic stimulation (non-treated night ). Comparison of apnea and hypopnea indices (AHI) and of oxygen saturation between the treated and non-treated night will be taken as indicators to quantify the performance of this potential new therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all the following criteria at the time of enrollment may be included:
- •Man or woman aged more than 18 years old.
- •Patient with severe obstructive apnea syndrome diagnosed on polysomnography or polygraphy performed less than 6 months ago with (AHI > 30/h and 80% of obstructive events) and (ODI 4% > 20 or time with SaO2 below 90% > 5%).
- •Patient free from continuous positive airway pressure (CPAP) treatment or any other SAS treatment for at least 3 months
- •Patient with no psychrotropic medication or stable psychotropic medication since the diagnostic polysomnography or polygraphy examination
- •Patient was informed and has signed the informed consent
排除标准
- •Patients who meet any one of these criteria will be excluded from the study:
- •Patients sleeping less than 4 hours per night
- •Patients suffering from respiratory failure, such as chronic obstructive pulmonary disease (COPD), pneumonia, pulmonary edema, pulmonary fibrosis, asthma, pulmonary arterial hypertension.
- •Patients developing periodic breathing or Cheyne Stokes respiration
- •Obese patient (BMI>35kg/m2)
- •Patient with autonomic dysfunction (symptoms include orthostatic hypotension, exercise intolerance, sweating abnormalities, digestion difficulties, urinary problems, vision problems) as complication of diabetes, Parkinson's disease or other primary pathologies.
- •Patient suffering from restless leg syndrome or periodic leg movement (PLM) not related to obstructive sleep apnea, i.e. PLM index > 15/h excluding movements linked to respiratory events.
- •Patient suffering from positional sleep apnea syndrome (SAS), i.e. supine apnea hypopnea index (AHI) at least twice that of the non-supine AHI
- •Patient suffering from severe peripheral neuropathy
- •Vulnerable patient in accordance with article L1121-6 of Code de la Santé Publique (CSP)
- •Patient already involved in another clinical study that could affect the result of this study
- •Pregnant patient
研究组 & 干预措施
Treatment ON
Kinesthetic stimulation administered during one night
干预措施: Kinesthetic stimulation (Device)
Treatment OFF
NO kinesthetic stimulation administered during one night
结局指标
主要结局
Rate of responder to the therapy
时间窗: Day 1 post-discharge
A patient is defined as 'responder' to the therapy by comparison of the treated night to the non-treated night based on: * The oxygen desaturation index (ODI) * The time spent below 90% of oxygen saturation or * The apnea hypopnea index (AHI) reduction
次要结局
- Adverse device effect(Day 1 post-discharge)
- Effect on apneas/hypopneas duration(Day 1 post-discharge)
- Effect on modified apnea hypopnea index(Day 1 post-discharge)
- Instantaneous heart rate measurement (bpm) during the night ON and the night OFF(Day 1 post-discharge)
- Number of arousals per night - comparison night ON and night OFF(Day 1 post-discharge)
- Effect on an objective measure of somnolence (Osler)(Day 1 post-discharge)