NCT03201055已完成不适用
Assessment of Performance, Usability and Acceptance of a Continuous Positive Airway Pressure System to Alleviate Self-reported Snore in Non-apnoeic Participants
ResMed1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年10月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Subjectively assess the participant and bed partner acceptability and usability of Snore PAP system
研究概览
简要总结
This study will aim to assess the acceptance of the Snore PAP system as a treatment concept for snore. The study will subjectively assess participant and bed partner acceptability and usability of the Snore PAP system and objectively assess participant compliance with the Snore PAP system.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants willing to provide written informed consent
- •Participants who can read and comprehend written and spoken English
- •Participants who are ≥ 18 years of age
- •Participants are CPAP naïve
- •Participants who are self/ partner reported snorers
- •Participants whose ApneaLink study results demonstrate snore
- •Participants who are willing to use Nice system in place of current non prescribed methods for alleviating snore
- •Participants have a bed partner
- •Participant's bed partner willing to answer assessment questionnaire
排除标准
- •Participants previously diagnosed with obstructive or central sleep apnoea
- •Participants whose ApneaLink home study indicates AHI ≥6
- •Participants who are pregnant or breastfeeding
- •Participants who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)
- •Participants with severe bullous lung disease, history of pneumothorax, pathologically low blood pressure, dehydration, cerebrospinal fluid leak, recent cranial surgery or trauma.
- •Participants who cannot participate for the duration of the trial
- •Participants who are established on bi-level support therapy
- •Participants currently using a prescribed medication/ device to alleviate snore
- •Participants who are physically unable to comply with the protocol- no access to internet to conduct online visits with researcher or unable to attend clinic for visit
研究组 & 干预措施
Non Apnoeic Snorers
Experimental
Patient's use the Snore Positive airway pressure device for 28 nights.
干预措施: Snore PAP System (Device)
结局指标
主要结局
Subjectively assess the participant and bed partner acceptability and usability of Snore PAP system
时间窗: 28 Nights
Subjective assessment will be assessed using the Likert scale using a 0-10 scale. With 0 being very negative and 10 being very positive.
次要结局
- Objectively assess participant compliance with the Snore PAP system(28 Nights)
- Subjectively assess the performance of the Snore PAP system in relieving: self-reported and bed partner reported snore in non-apnoeic participants.(28 Nights)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
3 期
Ayurveda Management Of Acute Excerbation Of Tamaka Shwasa(Bronchial Asthma) in ChildreCTRI/2023/08/056084SDM College of ayurveda and hospital Hassan
尚未招募
2 期
Ayurvedic management of hyperactive childreCTRI/2022/07/044380Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
招募中
4 期
Evaluation of efficacy and safety of ASPURUS for management of menopausal symptomsCTRI/2023/08/056569Waleria Healthtech Pvt. Ltd.,
已完成
不适用
A study to evaluate the safety and efficacy of AspireAssist™ in morbidly obese adolescentsAdolescent obesityNutritional, Metabolic, EndocrineISRCTN36495438Vítkovicke Hospital40
尚未招募
2 期
To Evaluate The Effectiveness Of Sarapanga Vilvathy Legiyam In The Treatment Of Acid Peptic Disease (Eri gunmam)CTRI/2023/09/057631ot Applicable