DRKS00023920招募中1 期
Evaluation of the response of sleeping obstructive sleep apnea (OSA) patients to electrical stimulation of the inner branch of the laryngeal superior nerve (iSLN)
MED-EL Elektromedizinische Geräte GmbH0 个研究点目标入组 80 人开始时间: 2020年12月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Male
入选标准
- •Age = 18 years
- •Male subjects with a previous clinical diagnosis of obstructive sleep apnoea
- •AHI between 15 and 30
- •BMI = 35
- •High motivation with realistic expectations regarding the participation in this study
- •Anatomic, physiological and mental conditions compatible with the participation in this study
- •Signed and dated informed consent before the start of any study-specific procedure.
排除标准
- •Lack of compliance with any inclusion criteria
- •Use of recreational drugs
- •Heavy smoker in past 2 years
- •Wearing an implantable active device (e.g. heart pacemaker)
- •Other clinical diseases that might result in sleep alterations: e.g. COPD, other pulmonary diseases, heart failure, other cardiac diseases, Cheyne-Stokes respiration, thyroid disease, psychiatric disorders, alcoholism or drug abuse, use of sleep inducing medications, epilepsy, hypoventilation syndrome, insomnia, narcolepsy, night terrors, parasomnias, nocturia, rhythmic movement disorder (RMD), periodic limb movement disorder (PLMS), or other neurological disorders
- •Infection of the upper airway or nasal congestion
- •Previous history of dysphagia or other swallowing disorders, laryngospasm, cancer of the head or neck
- •Tracheostomy, UPPP, or other surgical intervention for apnoea with the exclusion of nose-related surgeries, tonsillectomies and/or adenoidectomies
- •Concomitant use of propranolol, sulpiride, carbamazepine, dextromethorphan, sleep aids, or other current medications known to interfere with sleep, swallow, or breathing
- •Nose, mouth or head injuries
- •Bleeding disorders, clotting problems, use of anticoagulants
- •Known allergies or intolerance to the material used for this study
- •Current participation in other drugs and/or medical device studies that can affect the results of the present trial
- •Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this study
研究者
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