Acquired Brain Injury (Including Stroke)NODSNCT07215195
Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury
An observational study of Acquired Brain Injury (Including Stroke), run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury (Including Stroke)
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2025to 30 Nov 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, age 18 years or over (no upper age limit) within one year of acquired brain injury (stroke, haemorrhage, trauma)
Who may be able to join
- 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).
- Participants with Traumatic Brain Injury will have a Mild (probable) or Moderate-severe (definite) brain injury according to the Mayo classification
- Participants must be willing to consent to us contacting their general practitioner (GP) or direct care team if we have concerns about their mental health
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Centre for Integrative Neuroimaging (WIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford OX3 9DU
Oxford, OX3 9DU
Melanie Fleming, PhD, 00 44 1865 611 461, melanie.fleming@ndcn.ox.ac.uk
About this study
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.
Read more
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.
Read the detailed description
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:
- For a subset of participants we will provide a sleep mat to keep under their mattress continuously until they reach 12 months post-injury. This is to explore changes in sleep continuity/disruption and sleep timing long-term.
- For a subset of participants we will assess motor impairment/function of the upper limb (arm) and lower limb (leg) at each time point using clinical/research assessments: the Fugl Meyer assessment, Action Research Arm Test, Box and Blocks test, and the Rivermead Mobility Index.
- Conditions
- Acquired Brain Injury (Including Stroke)
- Keywords
- stroke, traumatic brain injury, neuropsychiatric disorder, movement, sleep, brain injury
- Medical subject headings
- Brain Injuries, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with acquired brain injury | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (first assessment, obtained within 12 months of acquired brain injury)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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%
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, and at 3-monthly intervals until the patient reaches 12 months following acquired brain injury (up to 4 assessments per participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start10 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury (Including Stroke)Studies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Fleming, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215195
- Sponsor's protocol ID
- PID 18842
- Acronym
- NODS
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data will be available upon reasonable request to Melanie Fleming