REducing Sleep Apnoea for the PrEvention of Dementia (REShAPED): a multi-site feasibility randomised controlled trial

The University of Sydney0 个研究点目标入组 180 人开始时间: 2021年9月6日最近更新: 2022年6月13日

适应症

试验速览

暂无简介。

•1.Subjective cognitive decline (new onset cognitive decline within the last 5 years)
•2.Able to provide informed written consent
•3.Fluent English literacy
•4.Adults aged between 50-75 years
•5.Mild – Severe OSA based on an average ODI equal to or greater to 10 with 3% oxygen desaturation determined by oximetry over two nights.

•1.Previous or current CPAP or mandibular device or oxygen user or body position device user (within past 3 months)
•2.People highly dependent on medical care
•3.Previous diagnosis of dementia or MMSE less than 24
•4.Previous major head injury or loss of consciousness equal to or greater than 30 minutes
•5.Previous or current substance misuse or use of medicinal cannabis
•6.Previous or current neurological disorder diagnosis (e.g. Parkinson’s, multiple sclerosis, epilepsy, stroke)
•7.Psychiatric or developmental disorders (e.g. Schizophrenia, bipolar disorder, autism)
•8.Current major depression diagnosis
•9.Major sleep disorders (e.g. narcolepsy, severe restless legs syndrome, severe insomnia disorder unrelated to a sleep-breathing disorder)
•10.Shift workers
•11.Any other condition that would, in the Investigator’s judgment, contraindicate the patient’s participation in the clinical study due to safety concerns or compliance with clinical study procedures.
•12.Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment.
•13.Prohibited medications
•Ongoing use of Anti-psychotic medication, mood stabilizers, benzodiazepines, wakefulness promoters and stimulants. Stable dosing (30 days prior to enrolment) of anti-depressants for non-major depressive disorder permitted. Melatonin or Circadin to be ceased before randomisation

发起方