Skip to main content
MedPathMedPath Home
Clinical Trials/ISRCTN11468655
ISRCTN11468655
Active, not recruiting
未知

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

niversity of Bristol0 sites12 target enrollmentAugust 12, 2021
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Bristol
Enrollment
12
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 12, 2021
End Date
September 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Bristol

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Study of treatment of a blood clot located in the pulmonary artery(ies), to find the optimum duration of ultrasound and dose of a clot dissolving drug.Submassive pulmonary embolismTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2016-000502-11-GBEKOS Corporation150
Recruiting
Not Applicable
Checking the effectiveness of a new hearing assessment (Oto-acoustic Emission) in identifying hearing loss caused due to Cisplatin (widely used as part of cancer treatment) in adult cancer patients.Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
CTRI/2023/12/060500Tata Research Administrative Council
Recruiting
Not Applicable
Checking the feasibility of a new hearing assessment tool(Oto-acoustic Emission) in identifying early and significant amount of hearing loss caused due to Cisplatin (widely used as a chemotherapy drug in cancer patients) chemotherapy in pediatric cancer patients.
CTRI/2023/03/051221Tata Research Administrative Council
Completed
Not Applicable
The effect of Organized auditory stimulation with familiar voices on the level of consciousness and hemodynamic status of coma patientsHead Trauma,Brain injury,Intracranial injury.Multiple injuries of head,Other specified injuries of head,Intracranial injuryS09.7,S09.
IRCT2014051517693N1Vice-Chancellor for Research of Guilan University of Medical Sciences60
Not yet recruiting
Not Applicable
Improving sleep quality and cognitive functions and psychotherapy during sleepImproving sleep quality and cognitive functions using simultaneous auditory and electrical stimulation, psychotherapy during sleep through meaningful auditory stimulation.
IRCT20230527058307N1Tabriz University of Medical Sciences131