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RecruitingNCT06839950EVAL-APAISEUpdated Oct 30, 2026

Sensory Profile and Early Clinical Signs of Calm Room Users

An observational study in Psychotic Disorders, Personality Disorders and Mood Disorders, sponsored by Centre Hospitalier Esquirol. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Centre Hospitalier Esquirol · Observational

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 10 months later.
Updated Oct 30, 20261 site added1 site removedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This descriptive study aims primarily to characterize the sensory profile of patients in a closed psychiatric hospital unit who use a calming room.

The main questions it aims to answer are :

  • Could sensory information processing disorders be the cause of distress and tension in these patients?
  • Could users of the calming room present extreme sensory processing profiles, characterized by either hypersensitivity or hyposensitivity ?

Participants will answer a survey to determine their the sensory profile. Participants can already use the calming room as part of their regular medical care and they will answer surveys before and after each use.

02

Conditions studied

  • Psychotic Disorders
  • Personality Disorders
  • Mood Disorders

Keywords

  • Calm room
  • Psychotic Disorders
  • Sensory Profile
  • Mood Disorders
  • Personality Disorders
03

In context

Psychotic Disorders

1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.

This study's planned enrollment of 80 is below the median of 123 across 221 observational studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

Centre Hospitalier Esquirol is the lead sponsor of 25 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be enrolled from the Deniker unit in the Esquirol Hospital Center of Limoges, France.

This study may involve a vulnerable population. In psychiatric settings, calming rooms are typically installed in closed units that admit crisis patients. These individuals may be hospitalized involuntarily or be under protective measures. Since the study focuses on individuals who are able to use such devices within the participating unit, they can be considered vulnerable.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gender and Age: Male or female, aged 18 to 65
  • Hospitalization: Admitted to the closed hospitalization unit for less than 10 days
  • Social security: Affiliated or beneficiary of a social security system
  • Consent: Free, informed, and written consent, signed by the participant and/or their legal representative (for participants under protection measures) and the investigator (at the latest on the day of inclusion and before any research-related examination).

Exclusion criteria

Exclusion Criteria:

  • Inability to understand information related to the study
  • Proven sensory disability
  • Dementia
  • Pregnancy
  • Lack of social protection
  • Previous Participation in this research protocol (in the case of a new hospitalization)
  • Expression abilities incompatible with completing the AASP Scale (e.g., french language comprehension issues, mute individuals, patients in restraint and/or therapeutic isolation)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • OtherCalm room

    The calm room combines the effects of music, light, and videos designed with natural atmospheres. Four themes are offered in the calm room: Comfort, Optimism, Freshness, and Lullaby. These themes feature nature videos, combining relaxing images with calm musical ambiance. The lighting can be adjusted by the user, who can choose from a varied color palette. The available lights have a low glare level, and the light intensity can also be adjusted by the user. They can be used by patients any time they want and for as long as they want.

    Also known as: Sensory room, Comfort room

06

What researchers measure

Primary outcomes

  1. Scores of Sensory Sensitivity from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room

    The sensory profile scores will be obtained through the Adolescent/Adult Sensory Profile (AASP) scale during an individual interview following the participant inclusion. The following Sensory Sensitivity sub-score will be collected. The minimum and maximum values are from 15 to 75. A high score indicate a high sensory sensitivity.

    Time frame: At enrollment

Secondary outcomes

  1. Scores of the Low Registration from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room

    The sensory profile scores will be obtained through the Adolescent/Adult Sensory Profile (AASP) scale during an individual interview following the participant inclusion. The following Low Registration sub-score will be collected. The minimum and maximum values are from 15 to 75. A high score indicate a high Low Registration.

    Time frame: At enrollment

  2. Scores of the Sensation Seeking from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room

    The sensory profile scores will be obtained through the Adolescent/Adult Sensory Profile (AASP) scale during an individual interview following the participant inclusion. The following Sensation Seeking sub-score will be collected. The minimum and maximum values are from 15 to 75. A high score indicate a high Sensation Seeking.

    Time frame: At enrollment

  3. Scores of the Sensation Avoiding from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room

    The sensory profile scores will be obtained through the Adolescent/Adult Sensory Profile (AASP) scale during an individual interview following the participant inclusion. The following Sensation Avoiding sub-score will be collected. The minimum and maximum values are from 15 to 75. A high score indicate a high Sensation Avoiding.

    Time frame: At enrollment

  4. Comparison of Adolescent/Adult Sensory Profile score between the user and non-user of the calming room

    * Adolescent/Adult Sensory Profile scores (Sensory Sensitivity / Low Registration / Sensation Seeking / Sensory Avoidance) among calming room user * Adolescent/Adult Sensory Profile scores (Sensory Sensitivity / Low Registration / Sensation Seeking / Sensory Avoidance) among calming room non-user

    Time frame: From enrollment to the end of observation at 2 weeks

  5. Anxiety for users or non-user of the calming room

    Anxiety is assessed from the Hamilton Anxiety Rating Scale for users and non-users of the calming room. The overall score ranges from 0 to 60. The generally accepted threshold for significant anxiety is 20.

    Time frame: From enrollment to the end of observation at 2 weeks

  6. Frequency of use of the calming room

    \- Frequency of Calming Room Use during the 14-Day Participation Period: Total number of uses of the room / time (hours)

    Time frame: From enrollment to the end of observation at 2 weeks

  7. Initiative for the use of the calming room

    Modes of use of the calming room among patients who use this room. Qualitative measure is used for initiative : Patient initiative or team initiative

    Time frame: From enrollment to the end of observation at 2 weeks

  8. Reason for resquesting of the calming room

    Modes of use of the calming room among patients who use this room. Qualitative measure is used for reason for resquesting use of the calming room : Anxiety / Sadness / Fatigue / Physical Tension / Seeking Well-being

    Time frame: From enrollment to the end of observation at 2 weeks

  9. Autonomy for the use of the calming room

    Modes of use of the calming room among patients who use this room. Qualitative measure is used for autonomy for the use of the calming room : Presence of caregiver / Partial autonomy (one-off intervention by a caregiver) / Total autonomy (nocaregiver intervention during the use)

    Time frame: From enrollment to the end of observation at 2 weeks

  10. User frenquecy of the calming room

    Number of uses of the calming room during the hospitalization

    Time frame: From enrollment to the end of observation at 2 weeks

  11. Description of anxiety leading to the use of the calming room among patients who use this room.

    Description of early clinical signs leading to the use of the calming room among patients who use this room. Visual Analog Score for anxiety

    Time frame: From enrollment to the the end of observation at 2 weeks

  12. Description of well-being leading to the use of the calming room among patients who use this room.

    Description of early clinical signs leading to the use of the calming room among patients who use this room. \- Visual Analog Score for well-being

    Time frame: From enrollment to the the end of observation at 2 weeks

  13. Description of physical tension leading to the use of the calming room among patients who use this room.

    Description of early clinical signs leading to the use of the calming room among patients who use this room. \- Visual Analog Score for physical tension

    Time frame: From enrollment to the the end of observation at 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Esquirol Hsopital Center
    Limoges, New Aquitaine 87025, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2023 (actual). Primary completion is estimated for Dec 2027, 48 months after the start.

Of 74 non-industry observational studies under Psychotic Disorders, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 124. This study's planned 48 months is below that.

Counting every sponsor, half of 76 studies reached it within 64 months; a quarter within 35 and three quarters within 124.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2025
First posted
Feb 21, 2025
StartActual
Dec 19, 2023
Primary completionEst.
Dec 19, 2027
CompletionEst.
May 19, 2028
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Esquirol Hsopital Center · Limoges, France
Show 1 removed
  • Esquirol Hsopital Center · Limoges, France
Oct 30, 2026
Secondary outcomes
3 description edited
What changed in the outcomes
  • DescriptionDescription of physical tension leading to the use of the calming room among patients who use this room.: how it is measured was reworded
  • DescriptionDescription of well-being leading to the use of the calming room among patients who use this room.: how it is measured was reworded
  • DescriptionFrequency of use of the calming room: how it is measured was reworded
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    1 site added, 1 site removed
    Show site
    • Esquirol Hsopital Center · Limoges, France
    Show 1 removed
    • Esquirol Hsopital Center · Limoges, France
    Secondary outcomes 3 description edited
    What changed in the outcomes
    • DescriptionDescription of physical tension leading to the use of the calming room among patients who use this room.: how it is measured was reworded
    • DescriptionDescription of well-being leading to the use of the calming room among patients who use this room.: how it is measured was reworded
    • DescriptionFrequency of use of the calming room: how it is measured was reworded
    + 3 other changes: index terms, verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06839950
Lead sponsor
Centre Hospitalier Esquirol
Responsible party
Aude Paquet (Psychomotor Therapist, Doctor in Psychology, Centre Hospitalier Esquirol) — Principal investigator
First posted
Feb 21, 2025
Start date
Dec 19, 2023
Primary completion
Dec 19, 2027 (estimated)
Completion
May 19, 2028 (estimated)
Last update
Oct 30, 2026

Study contacts

Aude Paquet, PhD in Psychology
Contact
aude.paquet@ch-esquirol-limoges.fr
+33 5-55-43-11-27

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

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