Polypathology and Autonomy LossSOLEIL SOMMEILNCT02829892
Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia
A study testing Light therapy in people with Polypathology and Autonomy Loss, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Polypathology and Autonomy Loss
- What is being tested?
- Light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Polypathology and Autonomy Loss
- Being tested
- Light therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light therapyDevice
14-days exposure with an innovative ambient light
| Study group | Role | What they receive |
|---|---|---|
| Light therapy | Other | Innovative ambient lighting Receives: Device: Light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration between 10 p.m to 5 a.m
Measured: 14 days
Secondary outcomes (4)
Sleep duration by day
Measured: 14 days
Number of awake between 10 p.m to 5 a.m
Measured: 14 days
Anxiety by the COVI scale
Measured: 14 days
Behavioral disorders by the NPI scale
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypathology and Autonomy LossStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829892
- Sponsor's protocol ID
- 14-PP-16
- Acronym
- SOLEIL SOMMEIL
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia
- ClinicalTrials.gov ID
- NCT02829892
- Acronym / sponsor ID
- SOLEIL SOMMEIL / 14-PP-16
- Conditions
- Polypathology and Autonomy Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light therapy | Other | Device: Light therapyInnovative ambient lighting |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light therapy14-days exposure with an innovative ambient light | Device | Light therapy |
Primary outcome
Sleep duration between 10 p.m to 5 a.m
Time frame: 14 days
4 secondary outcomes
Sleep duration by day
Time frame: 14 days
Number of awake between 10 p.m to 5 a.m
Time frame: 14 days
Anxiety by the COVI scale
Time frame: 14 days
Behavioral disorders by the NPI scale
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light therapy in people with Polypathology and Autonomy Loss, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration between 10 p.m to 5 a.m (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.