New device reads heartbeats to detect pain in silent patients
NCT ID NCT05454202
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a device called ANI that measures heart rate changes to assess comfort in patients who cannot speak, such as those in end-of-life care. Twenty non-communicating patients in a palliative care unit were monitored during a painful procedure. The device's readings were compared to standard pain scores from nurses to see if it could reliably detect discomfort.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ANI monitor (device that measures heart rate variability to assess comfort)
- What this could lead to
- If successful, this could give doctors a reliable way to check comfort in patients who cannot speak, improving end-of-life care.
- What could go wrong
- This is a very small, early study (20 people) and the device is not yet proven for this specific use. It may not work better than current methods.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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20 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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May 2024
- Lead sponsor
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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.
Who is studied
Non-communicating end-of-life patient hospitalized in palliative care
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Hospitalized in palliative care Non-communicating patients (Glasgow ≤ 10) Exclusion Criteria: * Non sinusal heart rate * Respiratory rate \< 9/min * Treated by inotropes * Pace-maker * Patient in agonal phase * Opposition from the guardian
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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
-
Hop Cardiologique Chu Lille
Lille, France
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