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Use of Connected Glasses to Help the Communication of Non Temporarily Speaking Patients in Intensive Care Unit : a Pilot Study (CASTOR-REA)

17. August 2026 aktualisiert von: Assistance Publique - Hôpitaux de Paris

Hospitalization in an intensive care unit (ICU) is accompanied by major physical and emotional stress for patients, a source of discomfort and a risk factor for post-resuscitation syndrome. Efficient patient-caregiver and patient-family communication is needed to: understand the patient's symptoms in order to relieve them, understand the patient's primary needs, understand the patient's questions and concerns in order to respond to them, rehumanize our care and re-establish a more balanced relationship with the patient. However, communication with the patient is often limited, due for example to invasive mechanical ventilation: it is estimated that half of intubated patients meet basic communication criteria (calm patient responding to simple commands and verbal requests) after 2 days of mechanical ventilation, without however being able to express themselves verbally.

Augmentative and alternative communication tools exist, ranging from pictograms and slates to voice synthesizers, and are used in ICU. The critical care departments of the University Hospitals of Marseille and Tours use a communication interface consisting of a mobile screen with eye tracking for vigilant patients unable to communicate verbally, which seems to have been appreciated by patients and their families, although its effect has not been measured.

Connected glasses are one of the tools available. These are pairs of glasses fitted with infrared sensors that detect a signal predefined with the patient (such as a wink) and thus enable a tablet with customized communication software to be clicked on and navigated. Potential advantages over eye tracking, which has already been used in critical care departments, include: use in low-light conditions, smaller size (no need for an arm to adjust screen orientation), less concentration (eye tracking requires precise, sustained eye fixation).

The objective is to conduct a pilot study to assess the feasibility of using this tool in non temporarily speaking patients hospitalized in ICU.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

  • The main objective of this pilot study is to evaluate the ability of ICU patients, who are vigilant but unable to communicate verbally, to use connected glasses as a communication aid.
  • The secondary objectives are to assess the limitations to the use of the communication aid and to measure the qualitative and quantitative impact of the communication tool.
  • Course of the study : Participation in the study is offered to any patient hospitalized in the department for a foreseeable period of ≥ 48 hours and whose clinical condition corresponds to the selection criteria. After oral and written information, the patient's non-opposition is collected and consigned in the information notice in the patient's file. Calibration of the connected glasses is carried out with the patient by trained medical and nursing staff (choice of personalized signal to control the cursor on the electronic tablet). Then, the connected glasses are put on the patient by the medical and nursing staff for an exchange session facilitated by the communication interface (no predefined duration): at least at each monitoring round (every 4 hours except during the night round if the patient is asleep) and during the medical visit each morning. Installation and actual use times are timed. Outcomes (see below) are collected on a Case Report Form (CRF) at the patient's bedside. Use of the connected glasses is temporarily suspended if the patient's condition no longer allows him/her to use it (onset of confusion, change in neurological status, deterioration in helath state). It may be resumed if the patient's condition subsequently improves.

  • The study ends:

    • when the patient is able to communicate verbally (e.g. extubation, decanulation) or using the slate (e.g. recovery of sufficient motor skills to use the slate correctly);
    • or when the patient is discharged from the ICU;
    • or after a maximum of 1 month's use of the tool for each patient.
  • After the study : there is no other data collected, the patient will not be contacted relating to the study.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Frankreich
      • Paris, Frankreich, 75020
        • Service Médecine Intensive Réanimation Tenon Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult patients hospitalized in the Intensive Care Medicine Department of the Tenon Hospital using connected glasses with electronic tablet and communication software

Beschreibung

Inclusion Criteria:

  • Adult patients hospitalized in the Intensive Care Medicine Department of the Tenon Hospital, whatever their reason for admission to the department
  • Neuropsychiatric state compatible with the development of a coherent dialogue: good vigilance attested by a RASS -1 to +1 (Richmond Agitation Sedation Scale), no confusion attested by a negative CAM-ICU test (Confusion Assessment Method for the Intensive Care Unit), no sedative treatment or light sedative treatment
  • Physically unable to communicate verbally for a foreseeable period of at least 48 hours, which may be linked to invasive mechanical ventilation (with endotracheal tube or tracheotomy without phonatory cannula) or to a speech and/or phonation disorder whatever the cause (eg: after-effects of ENT surgery, laryngeal oedema, etc.).
  • Have expressed no objection to participating in the study.

Exclusion Criteria:

  • Neuropsychiatric state incompatible with the development of a coherent dialogue: agitation (RASS ≥ 2) or somnolence (RASS ≤ -2), confusion (CAM-ICU positive)
  • Simple, fluid appropriation by the patient of the slate as a communication tool : no motor deficit of the dominant upper limb, no graphic problems, no language barrier
  • Inability of patient to use connected glasses: blindness, eye conditions preventing eye opening, vision disorders without corrective lenses available, known patent cognitive disorders, mental retardation

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Median daily time spent actually using the connected glasses during the study.
Zeitfenster: 7 month
This is the median of daily usage times from the beginning to the end of the study. Every day, the actual use of the tool (yes/no) is collected and the use of the connected glasses is timed (thanks to the stopwatch available on the patient monitor).
7 month

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To assess limitations to the tool use
Zeitfenster: 7 month
Tool installation time (timed by the caregiver interacting with the patient)
7 month
To assess limitations to the tool use
Zeitfenster: 7 months
reason for not using the tool (change in patient condition temporarily incompatible with use of the tool, occurrence of malfunctions)
7 months
To assess limitations to the tool use
Zeitfenster: 1 month
satisfaction questionnaire and profile (age, gender, function) of the member of the care team in charge of the patient
1 month
To assess limitations to the tool use
Zeitfenster: 7 months
occurrence of malfunctions (yes/no)
7 months
To assess limitations to the tool use
Zeitfenster: 7 months
type of malfunction (technical failure, battery not charged, unfamiliarity of caregivers with the tool, lack of space or inappropriate positioning of the tool, lack of caregiver time)
7 months
To assess the qualitative and quantitative impact of the communication tool
Zeitfenster: 1 month
Communication ease questionnaire (10-item Ease of Communication Scale using a 5-level Likert scale, previously validated in psychometrics)
1 month
To assess the qualitative and quantitative impact of the communication tool
Zeitfenster: 1 month
satisfaction questionnaire and profile (age, sex) of the doctor in charge of the patient, administration of psychotropic drugs (molecules and doses)
1 month
To assess the qualitative and quantitative impact of the communication tool
Zeitfenster: 1 month
use of physical restraint (yes/no)
1 month

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Assistance Publique - Hôpitaux de Paris

Ermittler

  • Hauptermittler: Audrey BARON, PhD, Assistance Publique - Hôpitaux de Paris

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. April 2028

Studienabschluss (Geschätzt)

1. Mai 2028

Studienanmeldedaten

Zuerst eingereicht

12. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. August 2026

Zuerst gepostet (Tatsächlich)

20. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • APHP250022

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

This is a pilot study with a small sample size, there will be no need for secondary research.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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