Safe & Easy for Alzheimer's Disease and Related Pathologies

NCT ID: NCT02518243

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-03-22

Brief Summary

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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.

Detailed Description

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The non pharmacological therapeutic will be install at hospital room :

* aromatherapy,
* music therapy,
* cognitive training in multimedia application offering cognitive games.

Conditions

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Cognitive Deterioration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Alzheimer's Disease

Group Type EXPERIMENTAL

Patient's answer with non pharmacological therapeutic

Intervention Type OTHER

Installation at patient's home of :

* aromatherapy
* music therapy
* cognitive training in multimedia application offering cognitive games

Interventions

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Patient's answer with non pharmacological therapeutic

Installation at patient's home of :

* aromatherapy
* music therapy
* cognitive training in multimedia application offering cognitive games

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

60 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renaud DAVID, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nice

Locations

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Ehpad Valrose

Nice, , France

Site Status

Countries

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France

Other Identifiers

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14-PP-08

Identifier Type: -

Identifier Source: org_study_id

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