An observational study in Acquired Brain Injury (Including Stroke), sponsored by University of Oxford. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University of Oxford · Observational
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.
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:
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 302 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients, age 18 years or over (no upper age limit) within one year of acquired brain injury (stroke, haemorrhage, trauma)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
We will follow adults with either stroke or traumatic brain injury for one year post-injury to examine the associations between sleep, mental health and motor recovery.
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)
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)
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)
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).
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).
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).
Sleep spindle power
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 continuity measures from a mattress sensor
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).
Symptoms of Depression
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).
Symptoms of Anxiety
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).
Symptoms of Post-traumatic stress disorder
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).
Symptoms of Insomnia
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).
Self reported sleep quality
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).
Fatigue symptoms
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).
Sleep Regularity Index
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: Baseline, and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
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 injury
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)
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)
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)
Mobility
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)
Estimated total sleep time
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)
Wake After Sleep Onset (WASO)
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)
Sleep efficiency
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)
Subjective sleep diary measures
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, and at 3 monthly intervals until 12 months following injury (up to 4 assessments per participant)
Current and past psychiatric disorder at baseline
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 (first assessment, within 12-months of acquired brain injury)
Presence of Sleep Disorders
Assessed using the Sleep Disorders Screening questionnaire. Positive responses within sub-groups of questions indicate potential presence of specific sleep disorders.
Time frame: Baseline, and at 3 monthly intervals until 12 months following injury (up to 4 assessments per participant)
Plan to share: Yes — Anonymous data will be available upon reasonable request to Melanie Fleming
Time frame: Data will be available following publication or public release of the main findings, for approximately 2 years.
Access criteria: Anonymous data will be available upon reasonable request to the Principal Investigator, using file transfer (e.g. Microsoft OneDrive).
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Dec 2028, 38 months after the start.
Of 143 non-industry observational studies under Brain Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 73. This study's planned 38 months is above that.
Counting every sponsor, half of 148 studies reached it within 31 months; a quarter within 16 and three quarters within 73.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Dec 2026 → Dec 2028 and completion Nov 2027 → Nov 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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