Relapsing-remitting multiple sclerosis (RRMS) Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Permuted block randomisation is conducted by the Bristol Trials Centre (https://bristoltrialscentre.blogs.bristol.ac.uk/).
Treatment arm: 2 weeks of consecutive nocturnal timed acoustic stimulation d
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of timed acoustic stimulation of sleep in multiple sclerosis, determined by: 1.1 Whether the pre-defined progression target is met; 50% of participants show a =10% increase in slow-wave activity (SWA, EEG power between 0.5-4Hz) induced by timed acoustic stimulation of non-rapid eye movement sleep. Measured at the end of 2 weeks timed acoustic stimulation (day 21 or day 42 depending on whether randomised to early or late stimulation) 1.2. Whether the target sample size of 12 is met within 6 months of the study opening to recruitment 1.3. Adverse events reported on Days 0-42 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neurophysiological parameters of sleep measured using electroencephalogram on days 0-42 2. Quality of sleep measured using a daily sleep evaluation questionnaire, sleep diary, Composite MotionWatch8 Sleep Quality Score and Pittsburgh Sleep Quality Index on days 0-42 3. Symptoms of multiple sclerosis measured using the MS Quality of Life-29 questionnaire, MS Impact Score (MSIS-29), Expanded Disability Status Scale (EDSS) and Brief International Cognitive Assessment for MS (BICAMS) on day 0, between days 21-28 and day 42 4. Quality of life measured using EQ-5D and Depression, Anxiety and Stress Scale – 21 items (DASS-21) on day 0, between days 21-28 and day 42 | — |
Countries
England, United Kingdom
Outcome results
None listed