Mechanical VentilationCASTOR-REANCT07776795
Use of Connected Glasses to Help the Communication of Non Temporarily Speaking Patients in Intensive Care Unit : a Pilot Study
An observational study of Mechanical Ventilation and Critical Care, Intensive Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Critical Care, Intensive Care, Artificial Respiration
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients hospitalized in the Intensive Care Medicine Department of the Tenon Hospital using connected glasses with electronic tablet and communication software
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service Médecine Intensive Réanimation Tenon Hospital
Paris, 75020
About this study
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.
Read more
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.
Read the detailed description
- 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.
- Conditions
- Mechanical Ventilation, Critical Care, Intensive Care, Artificial Respiration, Communication Aids
- Keywords
- Respiration, artificial, Communication aids for disabled, Augmentative and alternative communications systems
- Medical subject headings
- Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Median daily time spent actually using the connected glasses during the study.
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).
Measured: 7 month
Secondary outcomes (8)
To assess limitations to the tool use
Tool installation time (timed by the caregiver interacting with the patient)
Measured: 7 month
To assess limitations to the tool use
reason for not using the tool (change in patient condition temporarily incompatible with use of the tool, occurrence of malfunctions)
Measured: 7 months
To assess limitations to the tool use
satisfaction questionnaire and profile (age, gender, function) of the member of the care team in charge of the patient
Measured: 1 month
To assess limitations to the tool use
occurrence of malfunctions (yes/no)
Measured: 7 months
To assess limitations to the tool use
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)
Measured: 7 months
To assess the qualitative and quantitative impact of the communication tool
Communication ease questionnaire (10-item Ease of Communication Scale using a 5-level Likert scale, previously validated in psychometrics)
Measured: 1 month
To assess the qualitative and quantitative impact of the communication tool
satisfaction questionnaire and profile (age, sex) of the doctor in charge of the patient, administration of psychotropic drugs (molecules and doses)
Measured: 1 month
To assess the qualitative and quantitative impact of the communication tool
use of physical restraint (yes/no)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey BARON, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776795
- Sponsor's protocol ID
- APHP250022
- Acronym
- CASTOR-REA
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study with a small sample size, there will be no need for secondary research.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Connected Glasses to Help the Communication of Non Temporarily Speaking Patients in Intensive Care Unit : a Pilot Study
- ClinicalTrials.gov ID
- NCT07776795
- Acronym / sponsor ID
- CASTOR-REA / APHP250022
- Conditions
- Mechanical Ventilation, Critical Care, Intensive Care, Artificial Respiration, Communication Aids
- Keywords
- Respiration, artificial, Communication aids for disabled, Augmentative and alternative communications systems
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in the Intensive Care Medicine Department of the Tenon Hospital using connected glasses with electronic tablet and communication software
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median daily time spent actually using the connected glasses during the study.
Time frame: 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).
8 secondary outcomes
To assess limitations to the tool use
Time frame: 7 month
To assess limitations to the tool use
Time frame: 7 months
To assess limitations to the tool use
Time frame: 1 month
To assess limitations to the tool use
Time frame: 7 months
To assess limitations to the tool use
Time frame: 7 months
To assess the qualitative and quantitative impact of the communication tool
Time frame: 1 month
To assess the qualitative and quantitative impact of the communication tool
Time frame: 1 month
To assess the qualitative and quantitative impact of the communication tool
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. This is a pilot study with a small sample size, there will be no need for secondary research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey BARON, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Critical Care, Intensive Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey BARON, PhD (+33 1 56 01 51 84, audreypaule.baron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median daily time spent actually using the connected glasses during the study. (time frame: 7 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.