Efficacy and tolerability of a novel adjustable mandibular advancement device (iSlpr®) for Obstructive Sleep Apnoea in adults: A pilot study

Prof Andrew Chan0 个研究点目标入组 5 人开始时间: 2021年3月19日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•1. New diagnosis of at least moderate OSA with an AHI of equal to or greater than 15 events per hour
•2. Aged 18 years and older
•3. At least two symptoms of OSA from the following:
•-Fragmented sleep
•-Witnessed apnoeas
•-Daytime sleepiness
•4. Willingness to provide informed consent and to participate in a 9 week trial of two novel oral appliances.
•5. Proficiency in English

•1. Very severe OSA classified as an AHI of equal to or greater than 50 events per hour and/or a minimum oxygen desaturation of equal to or less than 70%.
•2. Need for immediate treatment of OSA based on clinical judgement of sleep physician, including unstable comorbidities or driving risk (e.g. commercial drivers)
•3. Co-existing sleep disorders or Central Sleep Apnoea
•4. Regular use of sedatives or narcotics
•5. Any contraindication for oral appliance therapy including poor oral hygiene, mobile teeth, temporomandibular dysfunction, other oral conditions as deemed by the dentist
•6. Unstable psychiatric or psychological illness that would prevent accurate reporting
•7. Pregnancy
•8. Participant is unable to understand the research project.

发起方

Prof Andrew Chan