Oxford Centre for Integrative Neuroimaging (WIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford OX3 9DU
Oxford, OX3 9DU, United Kingdom
Location status: Recruiting
NCT Number: NCT07215195
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Oxford, OX3 9DU, United Kingdom
Location status: Recruiting
This is a cross-sectional and longitudinal observational cohort study to assess the relationship between sleep quality and neuropsychiatric symptoms in adults within 12 months of an acquired brain injury, including traumatic brain injury (TBI), ischaemic stroke or haemorrhage. We hypothesise that participants with poor sleep quality will have worse neuropsychiatric (mental health) symptoms and slower recovery.
Participants will be identified at least one week, but less than 12 months, after brain injury from: a) National Health Service (NHS) sites; b) advertisements; and c) previous studies where patients have consented to be contacted about future studies.
The primary aim is to test whether adults with acquired brain injury and poor sleep quality (defined as a cut-off of >5 on the Pittsburgh Sleep Quality Index; PSQI) have a greater neuropsychiatric symptom burden (assessed with the diagnostic and statistical manual of mental disorder ver sion (DSM-5) Cross-Cutting Measure Level 1 Total Score) than those with good subjective sleep quality.
Secondary outcomes will test whether both self-reported and objective markers of sleep disruption (derived from actigraphy, brain activity and sleep mat data) relate to neuropsychiatric symptoms over time.
Two optional sub-studies will assess: a) long term sleep mat derived metrics (the participant will be asked to have a sleep mat on their bed at home for one year), and b) the association between sleep and changes in motor function over time.
Baseline clinical and demographic characteristics will be gathered from medical records and/or using questionnaires.
For the main objective of the study (cross-sectional assessment), we will collect data at a single time point (baseline). Following informed consent, we will assess sleep quality using the Pittsburgh Sleep Quality Index questionnaire (PSQI) and Neuropsychiatric symptoms using the Diagnostic and Statistical Manual (DSM-5) Cross-Cutting measure (DSM-5 CCM) level 1 total score.
For the secondary objectives, we will collect data at as many time points as the participant is able and willing to complete. Assessments will be at 3-monthly intervals until the participant reaches 12 months post-injury, thus some participants will complete more assessments than others. Secondary measures regarding sleep and neuropsychiatric symptoms will be assessed with self-report questionnaires at each time point: Pittsburgh Sleep Quality Index questionnaire (PSQI), sleep diary (SD; daily for 2 weeks), insomnia severity index (ISI), Fatigue Severity Scale (FSS), patient health questionnaire (PHQ-8), generalized anxiety disorder questionnaire (GAD-7), DSM-5 Cross-Cutting measure (DSM-5 CCM) Level 1 (total), primary care post-traumatic stress disorder questionnaire (PC-PTSD). We will also obtain information regarding the patient's location at the time of assessment (e.g. hospital, neurorehabilitation unit, home), medications and any sleep or mental health treatments they have received.
We will collect 'objective' sleep measures which will include using a waterproof actigraphy monitor worn on the least-affected wrist (2 weeks at each assessment period), a portable brain activity (electroencephalography) monitor to wear on their head during sleep (3-5 nights at each timepoint) and a sleep mat which goes under the bed mattress (2 weeks at each timepoint).
There are two optional sub-studies:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline (first assessment, obtained within 12 months of acquired brain injury)
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)
Assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Range 0-21, higher scores indicate worse sleep quality.
Time frame: Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)
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 the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
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).
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).
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).
Assessed with electroencephalography over 3 nights. Power, in decibels. Minimum value 0, no specified maximum value. Higher values indicate higher power of the sleep spindle frequency brain activity.
Time frame: Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
Sleep measures assessed using Withing's sleep analyser under-mattress sensor over a two week period (e.g. apnea episodes, time in each sleep stage, sleep duration, 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).
Assessed using the Patient Health Questionnaire (8-item), range 0-24 (higher values indicate more depressive symptoms)
Time frame: Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
Assessed using the Generalised Anxiety Disorder - 7 item (GAD-7) questionnaire. Scores range from 0-21, higher values indicate more anxiety symptoms.
Time frame: Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
Assessed with the Primary Care Screen for DSM-5 (PC-PTSD-5), scores range from 0-5, higher values indicate more severe postraumatic stress disorder symptoms.
Time frame: Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
Assessed using the Insomnia Severity Index (ISI) questionnaire. Range 0-28, higher scores indicate more severe symptoms of insomnia.
Time frame: Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
Assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Range 0-21, higher scores indicate worse sleep quality.
Time frame: Baseline and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
Assessed using the Fatigue Severity Scale (FSS) questionnaire. Scores range from 0-63, higher values indicate worse fatigue.
Time frame: Baseline, and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
Assessed using actigraphy (wearable activity monitor) over two weeks. Score 0-100, higher values indicate more regular sleep-wake patterns. There are no units associated with the sleep regularity index.
Time frame: Continuous from baseline until 12 months after acquired brain injury
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: Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)
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)
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)
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)
Assessed using the Rivermead Mobility Index. Range 0-15, higher score indicates better functional mobility
Time frame: Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)
Assessed using actigraphy (wearable activity monitor) over a two-week period. Time, in minutes. Higher values indicate longer sleep time
Time frame: Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)
Assessed using actigraphy (wrist worn activity monitor) over two weeks. Time, in minutes. Minimum value=0, no maximum value. Higher value indicates worse sleep
Time frame: Baseline, and at 3-monthly intervals until 12 months following injury (up to 4 assessments per participant)
Assessed using actigraphy (wrist worn activity monitor) over two-weeks. Score is the percentage of time in bed spent asleep. Range 0-100%. Lower sleep efficiency indicates worse sleep
Time frame: Baseline, and at 3 monthly intervals until 12 months following injury (up to 4 assessments per participant)
Assessed using sleep diary data collected over two weeks (e.g. estimated time to get into bed, sleep onset latency, total sleep time, wake after sleep onset, rise time).
Time frame: Baseline (first assessment, within 12-months of acquired brain injury)
Assessed using a brief questionnaire based on ICD-11 criteria for depression, generalised anxiety disorder, panic disorder, obsessive compulsive disorder, agoraphobia, adjustment disorder, bipolar disorder and psychosis.
Time frame: Baseline, and at 3 monthly intervals until 12 months following injury (up to 4 assessments per participant)
Assessed using the Sleep Disorders Screening questionnaire. Positive responses within sub-groups of questions indicate potential presence of specific sleep disorders.
Contact information is provided by the study sponsor or research team.
Brent Elliott, MBBBS MSc
CONTACT
Melanie Fleming, PhD
CONTACT
University of Oxford
Other
Acronym: NODS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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