Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Oxford
About this trial
The two most common causes of brain injury are stroke and trauma. Both sleep and mental health problems are common after brain injury; we will investigate whether there is a relationship between poor sleep quality and worse mental health in this group. We will also follow patients up, at approximately three-monthly intervals until one year after injury, to see how sleep and mental health symptoms change over time and with recovery.
We will assess sleep in detail using questionnaires, a sleep monitor worn on the wrist, a portable brain activity sensor, and a sleep mat. We will assess mental health (neuropsychiatric) symptoms using questionnaires.
Participants will be asked to complete these assessments at baseline and at approximately 3-monthly intervals until they reach 12 months post-injury.
This data will allow us to explore the types of sleep disruption seen after brain injury and examine the association between sleep and mental health symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to give informed consent for participation in the study.
Aged 18 years or above.
At least one week, but less than 12 months post-injury
Clinical diagnosis of acquired brain injury (stroke, haemorrhage or traumatic).
Disqualifiers
Brain injury not caused by trauma, haemorrhage or stroke
Previous brain injury.
Other relevant neurological conditions which could affect outcome measures (e.g., Parkinson's or Alzheimer's disease)
No stable and suitable place to sleep
Trial population
Adult patients, age 18 years or over (no upper age limit) within one year of acquired brain injury (stroke, haemorrhage, trauma)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Adults with acquired brain injury
Trial outcomes
Primary outcomes
1
Neuropsychiatric (mental health) symptoms at baseline
Assessed using the Diagnostic and Statistical Manual version 5 (DSM-5) Cross-Cutting Measure questionnaire level 1 total score. Range 0-92, higher scores indicate worse neuropsychiatric symptoms.
Time frame
Baseline (first assessment, obtained within 12 months of acquired brain injury)2
Self reported sleep quality at baseline
Assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Range 0-21, higher scores indicate worse sleep quality.
Time frame
Baseline (first assessment, obtained within 12 months of acquired brain injury)Secondary outcomes
1
Neuropsychiatric (mental health) symptoms
Assessed using the Diagnostic and Statistical Manual version 5 (DSM-5) Cross-Cutting Measure questionnaire level 1 total score. Range 0-92, higher scores indicate worse neuropsychiatric symptoms.
Time frame
Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)2
Sleep Fragmentation Index
Assessed using actigraphy (wearable activity monitor) over two weeks. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software which does the calculation the definition of sleep fragmentation index is "the sum of the Mobile time (%)' and the 'Immobile bouts \<=1min".There are no units associated with sleep fragmentation.
Time frame
Baseline, and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).3
Time in each stage of sleep
Electroencephalography (EEG) headband for assessing sleep measures over 3 nights. Time spent in each stage of sleep, in minutes as a percentage of the total sleep time. Stages include Non-rapid eye movement (NREM) sleep 1, 2 and 3. Range 0-100%
Time frame
Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).4
Slow wave sleep (SWS) amplitude
Assessed with electroencephalography over 3 nights. Amplitude, in microvolts. Minimum value 0, there is no specified maximum value. Higher values indicate larger (higher amplitude) slow wave oscillations in the brain.
Time frame
Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).Other outcomes
1
Sleep continuity assessed with a mattress sensor
Time-series (longitudinal) assessment of sleep measures using the Withings under mattress sleep sensor kept in place for the duration of the study (e.g. (e.g. apnea episodes, time in each sleep stage, sleep duration, sleep fragmentation).
Time frame
Continuous from baseline until 12 months after acquired brain injury2
Motor impairment
Assessed using the Fugl Meyer Assessment. Range 0-100, lower score indicates worse motor impairment
Time frame
Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)3
Upper limb ability
Assessed using the Action Research Arm Test. Range 0-57, higher score indicates better upper limb ability
Time frame
Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)4
Hand function
Assessed using the Box and Blocks Test, as the number of blocks moved in 60 seconds. Minimum value 0, no specified maximum value. Higher score indicates better hand function.
Time frame
Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)Sponsors and contacts
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Source ClinicalTrials.gov