Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia

NCT ID: NCT02829892

Last Updated: 2016-07-12

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

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Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment.. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light nighttime sleep of residents.

Detailed Description

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Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment. In 2014, the Cochrane published a systematic review of the literature over the last 20 years concerning the use of light therapy in patients with a AD. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light therapy (from 5 a.m to 10 p.m) on nighttime sleep of residents. Secondary objectives were the study of sleep time on the day, anxiety by the COVI scale and behavioral disorders by the NPI scale.

Conditions

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Polypathology and Autonomy Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Light therapy

Innovative ambient lighting

Group Type OTHER

Light therapy

Intervention Type DEVICE

14-days exposure with an innovative ambient light

Interventions

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Light therapy

14-days exposure with an innovative ambient light

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* EHPAD residents at Les Pastoureaux Valenton having moderate to severe MASA
* More than 60 years
* Presenting motor behavioral disorders and / or anxiety and / or restlessness and / or insomnia .
* No underlying acute medical problems including no delirium

* total acquired or congenital blindness
* bedridden patient ( loss of physical autonomy)
* Entry to the residence less than 15 days before the start of the experiment.

Exclusion Criteria

* Residents refusing to lend to experimentation
Minimum 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

Locations

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EHPAD ORPEA Valenton

Valenton, , France

Site Status

Countries

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France

Other Identifiers

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14-PP-16

Identifier Type: -

Identifier Source: org_study_id

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