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Robot seal calms dementia patients during care

NCT ID NCT04941222

Symptom relief Sponsor: Centre Hospitalier Departemental Vendee 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study tested whether a robotic seal named PARO could help elderly people with moderate to severe memory problems feel calmer during daily care like bathing. The robot was used for a few minutes before and during care, twice a week for 16 weeks. The goal was to see if it reduced agitation and anxiety, and if it was worth the cost. The study was stopped early and included only 33 people, so the results are not conclusive.

What this could mean

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

Active substance
PARO robotic seal
What this could lead to
If it works, this could offer a drug-free way to calm agitation and anxiety during daily care for people with dementia.
What could go wrong
The trial was terminated early with only 33 participants, so results are limited. The robot may not work for everyone, and cost savings are uncertain.

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

33 people

The number who actually took part.

Started

Jul 2021

Finished

Apr 2023

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

70 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: * Patients over 70 years of age * With moderate or severe neurocognitive disorders of any etiology (Mini Mental State Examination (MMSE) less than or equal to 20, or not feasible) * Resident in EHPAD (establishment for dependent elderly people) or USLD (long-term care unit ) in permanent accommodation for more than 1 month at inclusion Exclusion Criteria: * Patient with presumed life expectancy of less than 3 months * Mini Mental State Examination (MMSE) not feasible for any reason other than cognitive impairment (e.g. stroke aphasia), without dementia * Known carrier of multi-drug resistant bacteria * Carrier of Pace-maker (precautionary advice from manufacturer) * Refusal to participate to the study (trusted person, guardian or curator or patient depending on the patient's mental state) * Patient under court protection * Prior inclusion in an interventional study that may alter the interpretation of the results of the analysis * Patient not affiliated to a social security system or beneficiary of such a system

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Conditions

The condition(s) this trial relates to.

cognitive disorder Cognitive Dysfunction

As listed by the trial registrant

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

Cognitive impairment

Contacts and locations

Locations

  • CHD Vendee

    La Roche-sur-Yon, 85925, France

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