Investigation of the Substantial Equivalence of a Novel Mandibular Advancement Device, iSlpr™, With SomnoDent® Classic, in a Non-inferiority Study, in the Treatment of Snoring and Mild to Moderate Obstructive Sleep Apnoea.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 主要终点
- AHI
研究概览
简要总结
The study is a thirty three week, prospective, open-label, randomized, parallel-group non-inferiority study.
The study aims to investigate the Substantial Equivalence of a novel mandibular device called iSlpr™, produced by BioAnalytics, to a currently approved device, SomnoDent® Classic, in the treatment of mild to moderate Obstructive Sleep Apnoea (OSA) and snoring.
详细描述
The objective of this study is to determine if the BioAnalytics device, iSlpr™, has a similar safety and efficacy profile to a commonly used device, SomnoDent® Classic, in the treatment of snoring and mild to moderate Obstructive Sleep Apnoea.
The target population will be males and females aged from 18 years to less than 75 years, who have been diagnosed with snoring and mild to moderate sleep apnoea.
Participants will remain on study from screening visit to end of study visit; a total of approximately 33 weeks.
This study includes -
- a screening period of up to 28 days
- a 2 week device initiation period
- a 24 week treatment period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older and younger than 75 years at time of screening
- •Snoring and mild to moderate sleep apnoea ( AHI > 5 and < 30 per hr)
- •Written informed consent
- •Able to complete the study procedures within the study timeline.
排除标准
- •Women who are pregnant or breast-feeding
- •Central sleep apnoea
- •Severe respiratory disorders
- •Loose teeth or advanced periodontal disease
- •Lateral bruxers
- •Full or partial dentures
- •Temporomandibular Joint (TMJ) abnormalities, pain or dysfunction
- •Other teeth, jaw or gum disorders would preclude use of the device
- •Cardiovascular comorbidities or stroke/heart attack in past 12 months
- •Drug-addiction
- •Major Depressive Disorder or psychosis
- •Undergoing concomitant therapy for OSA/Snoring
- •current or previous therapy with SomnoDent Classic
- •Professional drivers or machine operators required to be undertaking CPAP
结局指标
主要结局
AHI
时间窗: 24 weeks
Apnea Hypopnea Index
ODI
时间窗: 24 weeks
Oxygen Desaturation Index
次要结局
未报告次要终点