Safe & Easy for Alzheimer's Disease and Related Pathologies

Cognitive Deterioration Clinical Trial

— SaFEE2  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518243
• Other study ID #: 14-PP-08
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 22, 2017

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.

Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.

The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.

The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .

The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

Description:

The non pharmacological therapeutic will be install at hospital room :

• aromatherapy,

• music therapy,

• cognitive training in multimedia application offering cognitive games.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 22, 2017
• Est. primary completion date: March 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007).

• Score at Mini Mental Test (MMSE) =16.

• Subjects residing in nursing homes.

• Subjects beneficiaries of a social security scheme.

• Signature of free and informed consent.

Exclusion Criteria:

• Failure to pass the neuropsychological tests because of a sensory or motor deficit.

• Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions.

• Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation;

• Persons deprived of liberty (administrative or judicial).

Related Conditions & MeSH terms

• Cognitive Deterioration

Intervention

Other:
• Patient's answer with non pharmacological therapeutic
Installation at patient's home of : aromatherapy music therapy cognitive training in multimedia application offering cognitive games

Locations

Country	Name	City	State
France	Ehpad Valrose	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire		3 months