Feasibility study of timed acoustic stimulation to improve efficiency and restorative quality of sleep in people with relapsing-remitting multiple sclerosis

niversity of Bristol0 个研究点目标入组 12 人开始时间: 2021年8月12日最近更新: 2021年9月20日

适应症

试验速览

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•1. Able to provide written, informed consent prior to entry
•2. Age =18 years and =40 years
•3. Estimated Expanded Disability Status Scale (EDSS) =6 (able to walk but may use some assistance if required)
•4. Diagnosis of relapsing-remitting multiple sclerosis (McDonald criteria)
•5. Self-report non-restorative sleep, defined as sleep that is insufficiently refreshing

•1. Severe, chronic sleep disorder (e.g. insomnia, sleep apnoea, restless legs syndrome, narcolepsy based on review with study clinician)
•2. Travel with time zone shift >3 hours in the last 3 weeks
•3. Investigator anticipates poor compliance with the study protocol
•4. Major neurological or psychiatric condition other than RRMS
•5. Self-report of recurrent seizures/epilepsy or increased seizure risk (e.g. stroke, aneurysm, space-occupying lesion)
•6. Must not be taking:
•6.1. Noradrenergic, serotonergic, or anticholinergic medications, except if the participant has been on stable treatment (at least 3 months) for pain or mood disorders
•6.2. Opioids or sympathomimetics (e.g. amphetamines, epinephrine/adrenaline)
•6.3. Benzodiazepines
•7. Intolerance of actigraph or SmartSleep® headband
•8. Participating in a currently active interventional clinical study
•9. Active infection
•10. Positive COVID-19 test within last 28 days
•11. High temperature, continuous cough, loss of taste or smell within last 28 days

发起方

niversity of Bristol