NCT07243405招募中不适用
The Evaluation of Neuro Stimulation for Treatment of Sleep Disordered Breathing
Lunair Medical1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年7月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Safety Endpoint - assessment of procedure or device related adverse events
研究概览
简要总结
This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
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
- 否
入选标准
- •Subject does not tolerate, not compliant to, or have access to alternative Sleep Disordered Breathing treatments
- •Subject has moderate to severe sleep disordered breathing as diagnosed by PSG
排除标准
- •Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.
- •Any reason for which, in the judgement of the investigator, the subject is considered to be a poor study candidate
- •Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG.
- •Subject has a need for chronic supplemental oxygen therapy for any reason
- •Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness
- •Subject has severe chronic kidney disease
- •Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study
- •Subject conducts work or regular activities requiring vigilance
- •Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study
- •Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices
- •Subject has an active systemic infection at the time of implant
- •Subject has clinical evidence of immunodeficiency
- •Any condition likely to require future MRI or diathermy
- •Subject is pregnant
- •Subject has severe nasal obstruction that could restrict airflow
- •Subject has any trauma to the upper airway
- •Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat
结局指标
主要结局
Safety Endpoint - assessment of procedure or device related adverse events
时间窗: enrollment to 12 months post-implant
Incidence of adverse events (AEs) related to the Lunair system or procedure
次要结局
- Improvement in sleep disordered breathing per sleep study(six month, 12 month and 24 month post implant)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Deep Brain Stimulation (DBS) for the Suppression of TremorTremorAction TremorEssential TremorTremor, LimbNCT02087046Abbott Medical Devices127
已完成
3 期
Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)Ischemic StrokeNCT00419705PhotoThera, Inc660
已完成
不适用
Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)Overactive BladderNCT01125722Ethicon Endo-Surgery74
已完成
不适用
Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in AdolescentBipolar DisorderNCT05929183First Affiliated Hospital of Zhejiang University40
招募中
不适用
Bilateral Nucleus Accumbens Focused Ultrasound Neuromodulation for Stimulant Use DisorderPsychostimulant Use Disorder(PUD)NCT06474026Korea University Anam Hospital15