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Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia (SOLEIL SOMMEIL)

Primary Purpose

Polypathology and Autonomy Loss

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Light therapy
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Polypathology and Autonomy Loss

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  • Residents refusing to lend to experimentation
  • Resident who are not matching with the inclusion criteria
  • 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.

Sites / Locations

  • EHPAD ORPEA Valenton

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Light therapy

Arm Description

Innovative ambient lighting

Outcomes

Primary Outcome Measures

Sleep duration between 10 p.m to 5 a.m

Secondary Outcome Measures

Sleep duration by day
Number of awake between 10 p.m to 5 a.m
Anxiety by the COVI scale
Behavioral disorders by the NPI scale

Full Information

First Posted
July 8, 2016
Last Updated
July 8, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02829892
Brief Title
Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia
Acronym
SOLEIL SOMMEIL
Official Title
Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypathology and Autonomy Loss

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Light therapy
Arm Type
Other
Arm Description
Innovative ambient lighting
Intervention Type
Device
Intervention Name(s)
Light therapy
Intervention Description
14-days exposure with an innovative ambient light
Primary Outcome Measure Information:
Title
Sleep duration between 10 p.m to 5 a.m
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Sleep duration by day
Time Frame
14 days
Title
Number of awake between 10 p.m to 5 a.m
Time Frame
14 days
Title
Anxiety by the COVI scale
Time Frame
14 days
Title
Behavioral disorders by the NPI scale
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: Residents refusing to lend to experimentation Resident who are not matching with the inclusion criteria 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.
Facility Information:
Facility Name
EHPAD ORPEA Valenton
City
Valenton
ZIP/Postal Code
94460
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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