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Sleepio shows promise for Post-Stroke insomnia in small trial

NCT ID NCT04272892

Symptom relief Sponsor: University of Oxford Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether an online cognitive behavioural therapy program called Sleepio could improve sleep in people who have had a stroke. 86 chronic stroke survivors were randomly assigned to either use Sleepio for 6 weeks or receive a leaflet with basic sleep tips. The main goal was to see if Sleepio led to better sleep quality, measured by a standard questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Online cognitive behavioural therapy (Sleepio)
What this could lead to
If it works, this could offer a convenient, drug-free way to improve sleep quality for stroke survivors.
What could go wrong
This is a small, completed trial with 86 participants, so results may not apply to all stroke survivors. The intervention is behavioural, so benefits may vary and require consistent engagement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

86 people

The number who actually took part.

Started

Feb 2020

Finished

Jan 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * At least 18 years of age * At least 3 months post stroke * Interest in improving sleep * Can understand verbal and written English well enough to engage with the programme and study procedures (with assistance from carer if needed). * Reliable access to internet * Currently living in the United Kingdom * Current stable health Exclusion Criteria: * Serious physical health concerns with surgery scheduled in the next 5 months * Undergoing a psychological treatment programme for insomnia (with a health professional or online) * Pregnancy * Uncontrolled seizures * Untreated diagnosed obstructive sleep apnoea * Habitual night shift, evening or rotating shift-workers * Other serious clinical condition that may affect participation in the study

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Conditions

The condition(s) this trial relates to.

stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke

Contacts and locations

Locations

  • Wellcome Centre for Integrative Neuroimaging (WIN)

    Oxford, OX3 9DU, United Kingdom

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Other studies related to the condition(s) this trial covers.