Impact on upper airway mechanics of a built in oral appliance airway in patients with obstructive sleep apnoea.

Oventus Pty Ltd0 个研究点目标入组 22 人开始时间: 2016年9月22日最近更新: 2020年2月17日

适应症

试验速览

暂无简介。

•1.Age > 18 years old < 75
•2.Obstructive sleep apnoea as diagnosed by polysomnography
•a.In the last 2 years
•b.> 2 years and < 5 years from diagnosis if BMI and general health stable since diagnosis
•3.Already using an oral appliance for the treatment of OSA at least 5 nights per week
•4.Able to sleep in the supine position
•5.Able to provide written informed consent to all study procedures, investigators to access clinical records from treating physician and agrees to adhere to all protocol requirements.
•To continue on to Part 2, subjects must demonstrate the following from Part 1
•1.Supine AHI >15 and <60
•2.Total sleep time > 4 hours
•3.Demonstrated tolerance to instrumentation with more than 3 hours of supine sleep time with pharyngeal catheter and partitioned mask.

•1.Pregnant or lactating females
•2.Participating in another interventional clinical trial
•3.Primary snoring
•4.Uncontrolled or untreated cardiovascular disease
•5.Central Sleep Apnoea events (greater than or equal to 5/hr)
•6.Periodic limb disorder
•7.Previous Uvulopalatopharyngoplasty (UPPP)
•8.Medication usage that could influence respiration or sleep (e.g. regular use of sedatives, heavy alcohol consumption)
•9.Severe somatic or psychiatric disorders
•10.Periodontal disease, temporomandibular disorder or dental pain that would prevent ongoing suitability for an oral appliance
•11.Unable or unwilling to sleep with full face mask
•12.Strong gag reflex

发起方

Oventus Pty Ltd