Timed acoustic stimulation of sleep in relapsing-remitting multiple sclerosis
- Conditions
- Relapsing-remitting multiple sclerosis (RRMS)Nervous System DiseasesMultiple sclerosis
- Registration Number
- ISRCTN11468655
- Lead Sponsor
- niversity of Bristol
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method