NCT07559708尚未招募不适用
A Prospective, Open-label Study to Assess the Efficacy of the Elara APAP Device When Used in Patients With Obstructive Sleep Apnea
Sleepnet Corporation1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2026年4月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- AHI 4%
研究概览
简要总结
The goal of this study is to evaluate the effectiveness of the Elara APAP device.
详细描述
A prospective open label study to assess the efficacy of the Elara APAP device when used in patients with obstructive sleep apnea. Subjects will sign Informed Consent and undergo screening/baseline and a 1 night in-lab PSG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Body weight ≥ 30kg
- •Willing and able to consent, adhere to study requirements and receive mask treatment
- •≥ 18 years of age
- •Diagnosed with OSA (Total AHI >15 events/hr) by a practicing physician within the last 6 months. A re-diagnosis may be necessary to establish current baseline AHI in case there has been significant weight change or other co-morbidities since the previous diagnosis (per PI discretion)
- •Currently utilizing an APAP Device for ongoing treatment of OSA
排除标准
- •Body weight < 30kg
- •Female currently bearing a child or intending to become pregnant prior to the sleep study.
- •Have implanted pacemaker, ICD or any other medical device that would interfere with the PSG results or safety of the subject undergoing the study
- •Has pneumothorax, pneumomediastinum
- •Has history of Cerebrospinal fluid leakage, craniocerebral trauma, intracranial trauma or pneumocephalus
- •Ongoing shock from various causes untreated
- •Current epistaxis
- •Non-compliant with APAP usage (< 4 hours per night on 70% of nights)
- •Upper gastrointestinal bleeding that has not been effectively controlled
- •Has obstructive vocal cord polyps
- •Severe coronary heart disease with left heart failure
- •Acute otitis media inflammation (must be resolved prior to sleep study)
- •Excessive respiratory secretions and cough weakness
- •Weak spontaneous breathing
- •Tracheal intubation (nasal or oral) and tracheotomy
- •Severe nasal congestion from various causes
- •Lung bullae
- •Central sleep apnea index >5 events/hr
- •Have another significant sleep disorder(s) that in the opinion of the investigator would confound the results of the study (e.g. periodic leg movements >15/hr or insomnia that would interfere with completing the sleep study).
研究组 & 干预措施
Treatment
Experimental
Sleepnet Elara Treatment
干预措施: Sleepnet Elara Treatment (Device)
结局指标
主要结局
AHI 4%
时间窗: Day 1
The primary endpoint of this study is treatment night AHI 4%. A subject is considered a success if the Apnea Hypopnea Index calculated by using hypopneas that cause a 4% or greater drop in blood oxygen levels per hour of sleep (AHI4) measured during the 1-night treatment study (PSG) is less than 10 events/hour or less than 10% of the baseline AHI4 value determined at previous diagnosis, whichever is greater.
次要结局
未报告次要终点
研究者
研究点 (1)
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