- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02829892
Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia (SOLEIL SOMMEIL)
July 8, 2016 updated by: Centre Hospitalier Universitaire de Nice
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Valenton, France, 94460
- EHPAD ORPEA Valenton
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Light therapy
Innovative ambient lighting
|
14-days exposure with an innovative ambient light
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sleep duration between 10 p.m to 5 a.m
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sleep duration by day
Time Frame: 14 days
|
14 days
|
Number of awake between 10 p.m to 5 a.m
Time Frame: 14 days
|
14 days
|
Anxiety by the COVI scale
Time Frame: 14 days
|
14 days
|
Behavioral disorders by the NPI scale
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 8, 2016
First Submitted That Met QC Criteria
July 8, 2016
First Posted (Estimate)
July 12, 2016
Study Record Updates
Last Update Posted (Estimate)
July 12, 2016
Last Update Submitted That Met QC Criteria
July 8, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-PP-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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