Timed acoustic stimulation of sleep in relapsing-remitting multiple sc
Feasibility study of timed acoustic stimulation to improve efficiency and restorative quality of sleep in people with relapsing-remitting multiple sclerosis
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- SmartSleep®
What it measured
Main measures
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
Nerve conduction testsMood and sleepSafetyFeasibility
Other measures (1)
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 Di
Disability progressionThinking and memoryNerve conduction testsMood and sleepQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 40
Show the full criteria
Inclusion criteria
Inclusion: 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: 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Multiple sclerosis (MS) affects about 110,000 people in the UK and almost 2.5 million worldwide. Immune system abnormalities cause damage to nerves in the brain and spinal cord and their protective covering or ‘insulator’ known as myelin. This leads to disability which can include visual disturbance, lack of coordination, bowel and bladder symptoms and paralysis. Fatigue, depression and cognitive impairment occur in up to 95% people with MS with a negative impact on quality of life and employment. Over 70% of people with MS report sleep problems and these have been associated with MS-related symptoms and harmful effects on myelin in disease models. Currently, sleep abnormalities are poorly treated; available medications are of limited effectiveness and the side effects of treatment may make symptoms worse due to increased daytime sleepiness and confusion. In healthy people, improvements in sleep quality have been demonstrated with the delivery of soft sounds timed to occur during particular stages of sleep and coordinated with brain wave activity. This is known as ‘timed acoustic stimulation of sleep’ and has been shown to improve feelings of refreshment, well-being and memory, including in people with known impairment of thinking. Recently, Philips has developed a headband (SmartSleep®) that can be worn comfortably at night in the home but which also records brain wave activity and delivers sounds at the appropriate time during sleep. This study will examine whether SmartSleep® can improve sleep quality for people with MS with aim of reducing common MS symptoms including fatigue and memory problems and improving quality of life. Who can participate? People with relapsing-remitting multiple multiple sclerosis aged between 18 and 40 years who report sleep which is insufficiently refreshing. What does the study involve? Participants will be asked to wear a headband at night which plays soft tones during sleep as well as a wrist-worn monitor of activity. There will be a 1-week period of getting used to the headband, a 2-week 'sham' period, and a week between the active and placebo phases ('washout'), participants will be asked to wear the headband for 42 consecutive nights. All assessments will occur within this time period. Participants will need to attend the clinical unit for assessments including examination and memory tests and will be asked to keep a sleep diary and complete regular questionnaires. What are the possible benefits and risks of participating? People who do not have multiple sclerosis have been shown to have an improvement in sleep quality and memory with acoustic stimulation of sleep. It is hoped that people with multiple sclerosis will also experience this. The devices are commercially available and are not expected to carry additional risk to participants. Where is the study run from? Bristol Brain Centre, Southmead Hospital, Bristol and University of Bristol (UK) When is the study starting and how long is it expected to run for? December 2018 to September 2022 Who is funding the study? 1. Above and Beyond Charity (UK) 2. Bristol and Avon MS Charitable Funds (UK) Who is the main contact? Dr Claire Rice C.M.Rice@bristol.ac.uk
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History
Started
Nov 2021
Finished
Sept 2022