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CompletedNCT01819714SensiCareUpdated Apr 29, 2015

Sensory Support Care for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease

An interventional study of Multi-sensory supportive care in Alzheimer Disease, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-29.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.

Read the detailed description

The secondary objectives of this study are to study the following elements in relationship to the implementation of a "Snoezelen-type" multi-sensory care strategy for patients with Alzheimer's-type neurodegenerative disease:

A. to evaluate the effects on NPI-Q scores at 1 month, 6 months and 12 months .

B. evaluate the effects on quality of life (questionnaire QOL-AD) at 0 and 12 months.

C. assess changes in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire over 0, 1, 3, 6 and 12 months.

D. assess changes in drug consumption (anxiolytics, antidepressants, hypnotics, neuroleptics)over the study period

02

Conditions studied

  • Alzheimer Disease

Keywords

  • Snoezelen
  • Multi-sensorial care session
  • Alzheimer's-type neurodegenerative disease
  • Dementia
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 31 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The patient's legal representative must have given his/her informed and signed consent (or the patient if he/she is judged competent)
  • The patient must be insured or beneficiary of a health insurance plan
  • Alzheimer's-type neurodegenerative pathology
  • The patient has been living in the participating center for > 2 months

Exclusion criteria

Exclusion Criteria:

  • The patient's legal representative refuses to sign the consent (or the patient if he/she is judged competent)
  • It is impossible to correctly inform the patient's legal representative
  • The patient has already has Snoezelen-therapy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Study population

    Patients hospitalized at the Serre-Cavalier centre and who have Alzheimer's-type neurodegenerative disease (see inclusion criteria).

    Other: Multi-sensory supportive care

Interventions

  • OtherMulti-sensory supportive care

    The Serre-Cavalier center will implement Snoezelen-type multisensory care sessions for included patients; these care sessions correspond with the patients' daily hygiene/toilette care. The impact of this multisensory strategy will be evaluated using a before-after design.

    Also known as: Snoezelen-type care, Snoezelen toilette

06

What researchers measure

Primary outcomes

  1. Change from baseline in NPI-Q scores

    Time frame: 3 months

Secondary outcomes

  1. Change from baseline in NPI-Q scores

    Time frame: 1 month

  2. Change from baseline in NPI-Q scores

    Time frame: 6 months

  3. Change from baseline in NPI-Q scores

    Time frame: 12 months

  4. Change from baseline in the Quality-of-life-Alzheimer's Disease questionnaire (QOL-AD)

    Time frame: 12 months

  5. Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire

    Time frame: 1 month

  6. Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire

    Time frame: 3 months

  7. Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire

    Time frame: 6 months

  8. Change from baseline in the "aggressive behavior" subsection of the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire

    Time frame: 12 months

  9. Change in drug consumption from baseline

    Time frame: 1 month

  10. Change in drug consumption from baseline

    Time frame: 3 months

  11. Change in drug consumption from baseline

    Time frame: 6 months

  12. Change in drug consumption from baseline

    Time frame: 12 months

07

Study locations

1 site
  • CHU de Nîmes - Centre de Gérontologie de Serre Cavalier
    Nîmes, 30029, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01819714
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Mar 28, 2013
Start date
Jun 2013
Primary completion
May 2014
Completion
Feb 2015
Last update
Apr 29, 2015

Study contacts

Jane Debuysschere, IDE
study director · Centre Hospitalier Universitaire de Nîmes
Jean-Marie Cros, MD
principal investigator · Centre Hospitalier Universitaire de Nîmes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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