ClinicalTrials.gg
RecruitingNCT07934485FOSTERSUpdated Nov 13, 2026

Feasibility Of Sleep Treatment Education in Stroke Rehabilitation Settings

An interventional study of Sleep education package in Stroke, sponsored by University of Oxford. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by University of Oxford · Not applicable, Interventional, and Other

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Stroke by University of Oxford — 5 open to participants now, 6 under way, none of them phase 3. Stroke · University of Oxford.

Planned enrollment
5th of 11
80 · median 80
Started
2026
the only one that year
No phase
8 of 15
3 open now
Registered
15th of 15
by date

Among the 15 studies in Stroke by University of Oxford, this one is the 5th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2026, is one of 8 with no phase, and was the 15th registered.

Stroke

8,268 studies on the registry are indexed under Stroke; 2,062 are open to participants now.

Browse Stroke studies →

Open to participants now

5 of the 15 studies in Stroke by University of Oxford are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 1,418 Stroke studies recruiting now, 696 (49%) set no upper age limit and 282 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Stroke by University of Oxford, or all of them as a file.
02

Study summary

Stroke is a leading cause of disability with over 1 million people in the UK living with the effects of stroke. Sleep is important for many aspects of daily life, but there is growing evidence that people sleep worse after a stroke, and this impacts negatively on rehabilitation outcomes and quality of life. Stroke survivors have highlighted to us that it is difficult to sleep in the hospital after a stroke, and they feel that sleep isn't perceived as high priority despite clear importance for next day function and healing.

This project will develop and test a sleep education package for clinical staff and stroke survivors in the rehabilitation hospital. Specifically, we aim to (1) develop a training programme for staff and a toolkit of resources about sleep for staff and stroke survivors, (2) assess acceptability and usability of the package, and, following modifications, (3) assess the feasibility of delivery of the sleep education package and collecting data about patient's sleep.

03

Conditions studied

  • Stroke

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

Stroke survivors:

  • Neurorehabilitation unit inpatient
  • Clinical diagnosis of stroke
  • Aged 18 years or over
  • Willing and able to provide OR a positive opinion from a consultee is provided by a family member or carer (relative or friend) willing to provide personal consultee (PC) advice.

Staff:

  • Current stroke rehabilitation unit staff member, providing care to stroke survivors
  • Aged 18 years or over
  • Able and willing to provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Staff may not participate if they are anticipated to be leaving the neurorehabilitation unit within 2 months of the delivery of the sleep education package
  • Stroke survivors may not participate if they are anticipated to be discharged within 1 week of recruitment
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • No intervention
    Before sleep package implementation - patients

    Usual care prior to delivery of sleep package

  • Active comparator
    After sleep package implementation - patients

    Usual care plus sleep package

    Other: Sleep education package

  • No intervention
    After sleep package implementation - staff

    Staff sleep training implementation

Interventions

  • OtherSleep education package

    Staff and patients will receive sleep resources and staff will receive sleep training

06

What researchers measure

Primary outcomes

  1. Staff perceptions of the usefulness of sleep education package

    Proportion of staff who received the sleep package rating the package as useful, using a likert scale 4-point rating from 1=no definitely not, to 4=yes definitely

    Time frame: 2 months following enrolment

  2. Staff perceptions of the relevance of the sleep education package

    Proportion of staff who received the sleep package rating the package as relevant, using a 4-point likert scale from 1=no definitely not, to 4=yes definitely

    Time frame: 2 months following enrolment

  3. Staff perceptions of the appropriateness of the sleep education package

    Proportion of staff who received the sleep package rating the package as appropriate, using a 4-point likert scale from 1=not appropriate at all, to 4=very appropriate

    Time frame: 2 months following enrolment

  4. Patient perceptions of the usefulness of the sleep education package

    Proportion of patients who received the sleep package rating the package as useful. 10-point Likert scale rating for usefulness of resources, from 1=not useful at all, to 10=very useful.

    Time frame: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.

Secondary outcomes

  1. Patient perceptions of acceptability of measures that staff use to support sleep

    Likert scale rating of how acceptable they found measures that staff were using to try to support their sleep, from 1=not acceptable at all, to 10=very acceptable.

    Time frame: At discharge from rehabilitation unit (exact time from enrolment varies between participants depending on the length of their clinical stay in the rehabilitation hospital). Typically 1-4 weeks from enrolment.

  2. Self-reported sleep

    Sleep assessed using the Sleep Condition Indicator questionnaire (SCI), from 0-32, with higher values indicating better sleep

    Time frame: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.

  3. Sleep disruption

    Assessed using actigraphy (wearable activity monitor) over the duration of their stay in hospital from enrolment to discharge. 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: Continuous from recruitment till discharge from the rehabilitation unit. The exact timeframe will differ between participants depending on the length of their clinical stay in the rehabilitation hospital. Typically 1-4 weeks from enrolment.

  4. Sleep related impairment

    Sleep assessed using the Sleep related impairment questionnaire (SRI). Each question is scored from 1 to 5, yielding a raw total sum score from 8 to 40. Higher raw numbers mean worse daytime impairment. Raw scores are translated into a T-score using official lookup tables. Interpreting the T-Score: 50 or lower: Normal or better-than-average wakefulness/55 to 59 (0.5 to 1.0 SD above mean): Mild sleep-related impairment/60 to 69 (1.0 to 2.0 SD above mean): Moderate sleep-related impairment/70 or higher (2.0+ SD above mean): Severe sleep-related impairment.

    Time frame: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.

  5. Sleep disturbance

    Sleep assessed using the Sleep disturbance questionnaire (SD). 5-point Likert scale (1 = never to 5 = always) covering the past 7 days. Sum the raw scores (range 8-40) and use a standard look-up conversion table to change the raw total into a standardized T-score (mean = 50, standard deviation = 10). T-Score Interpretation: \< 55: None to slight sleep disturbance/55.0 - 59.9: Mild sleep disturbance/60.0 - 69.9: Moderate sleep disturbance/70 and over: Severe sleep disturbance

    Time frame: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.

  6. Perception of sleep quality

    Sleep assessed using the Richards-Campbell Sleep questionnaire. Scored by measuring 5 visual analog scale items from 0 to 100 millimeters. Each item score is summed and divided by 5 to yield a total score from 0 (worst sleep) to 100 (best sleep), with scores under 50 indicating poor sleep.

    Time frame: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.

  7. Sleep environment

    Sleep assessed using the sleep environment questionnaire (ASE). The Assessment of Sleep Environment (ASE) is a 13-item self-report questionnaire. Each item is rated on a 4-point Likert scale from 0 to 3 ("strongly disagree" to "strongly agree"). Summing all items yields a total score from 0 to 39, where higher scores reflect a more disruptive, poorer sleep environment.

    Time frame: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.

  8. Mood

    Mood assessed using the Patient Health Questionnaire (PHQ8). Each item is rated from 0 to 3 based on how often symptoms occurred over the past two weeks. Total scores range from 0 to 24. 0-4: No significant depressive symptoms/5-9: Mild symptoms/10-14: Moderate symptoms (a score of 10 or greater often indicates probable major depression)/15-19: Moderately severe symptoms/20-24: Severe symptoms

    Time frame: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.

  9. Fatigue

    Fatigue assessed using the Fatigue Severity Scale (FSS). Scores are evaluated by calculating the total sum (9 to 63) or the average mean (1 to 7). A mean score of 4.0 or higher (or a total sum of 36 or more) indicates clinically significant fatigue

    Time frame: At discharge from rehabilitation unit. Exact timing from enrolment varies depending on length of clinical stay in rehabilitation hospital. Typically 1-4 weeks from enrolment.

07

Study locations

1 of 1 sites recruiting
  • Oxfordshire Stroke Rehabilitation Unit
    Oxford, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Anonymous data will be shared upon request to the principal investigator

Supporting information: Analytic code

Time frame: Following publication of study results

Access criteria: Anonymous data will be shared by contacting the principal investigator

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.

Of 3,117 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 5 months is below that.

Counting every sponsor, half of 3,261 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 13, 2026
StartEst.
Nov 3, 2026
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07934485
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Nov 3, 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Melanie K Fleming, PhD
Contact
melanie.fleming@ndcn.ox.ac.uk
+441865611461
Julie Darbyshire, PhD
Contact
julie.darbyshire@ucl.ac.uk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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