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Can an app help people with dementia sleep better? small study tests digital CBT

NCT ID NCT07363928

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a digital program called Sleepio, which provides cognitive behavioural therapy for insomnia, could be used by people with mild cognitive impairment or mild dementia. Thirty participants were enrolled to see if the program was acceptable and easy to use. The goal was to gather information for a larger future trial, not to prove the treatment works.

What this could mean

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

Active substance
Digital cognitive behavioural therapy for insomnia (Sleepio)
What this could lead to
If this approach works, it could offer a non-drug way to improve sleep and quality of life for people with early memory problems.
What could go wrong
This was a very small feasibility study with only 30 participants, so results may not apply to everyone. The digital format may be difficult for some people with cognitive impairment to use.

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

30 people

The number who actually took part.

Started

Jan 2025

Finished

Sep 2025

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

50 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: 1. Age ≥50 years. 2. Sleep Condition Indicator Score ≤16/32. 3. Established Mild Cognitive Impairment (MCI) or mild dementia, diagnosed by a consultant physician specialised in cognitive disorders prior to enrolment in the study. Dementia will be defined using DSM-5 classification and staged according to the Reisberg FAST scale into early/mild stage (Stages 1-4). MCI will be defined using Petersen's criteria. To participate those with MCI/mild dementia must score: 1. ≥18 on the Mini-Mental State Examination (MMSE), and 2. ≥0.5-1.0 on the Clinical Dementia Rating (CDR) scale. 4. Internet access for the duration of the intervention (via computer/tablet/smartphone). 5. Sufficient physical/sensory (visual/hearing) capacity to use the intervention, as judged by the clinician/investigator. 6. English-speaker (intervention only available in English). 7. Community-dwellers (non-institutionalised). Exclusion Criteria: 1. Known history of an International Classification of Diseases (ICD) defined sleep disorder other than insomnia disorder. 2. Receipt of a sleep-related cognitive behavioural therapy (CBT) intervention within the past six months. 3. MMSE score \<18 at enrolment, to facilitate adherence and ensure recruitment of those with mild-stage disease. 4. Severe depression (defined as depression requiring hospitalisation in the past 12-months or visit to psychiatry outpatient clinic in the past 3 months). 5. Unstable depression/anxiety disorders or panic attacks (unstable will be defined as changes in antidepressant medications within the last 3 months, i.e. no start, stop or change in dose). 6. Other relevant major neuropsychiatric disorders, including schizophrenia, psychosis, mania, bipolar affective disorder, epilepsy or seizure disorder. 7. Ongoing substance or alcohol abuse. 8. Long-term physical or sensory impairment, pain or other medical condition which, in the opinion of the principal investigator, could impair participation for reasons other than cognitive impairment. 9. Planned surgery or hospitalisation during the study that could interfere with participation. 10. Medical conditions rendering the patient too unwell to continue to participate in the study in the opinion of the principal investigator. 11. A change in the following medication within the three months prior to enrolment: 1. Benzodiazepine and non-benzodiazepine hypnotic or anxiolytics agents 2. Cholinesterase inhibitors or Memantine 3. Antidepressants 4. Antipsychotics 5. Amphetamine derivatives 6. Decongestants (pseudoephedrine, phenylephrine, phenyl¬propanolamine) 7. Narcotic analgesics 8. β-Blockers 9. Pulmonary medications (theophylline and albuterol) 10. Melatonin

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mercy University Hospital

    Cork, Ireland

More trials for these conditions

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