NCT02829892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

July 8, 2016

Last Update Submit

July 8, 2016

Conditions

Polypathology and Autonomy Loss

Outcome Measures

Primary Outcomes (1)

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

    14 days

Secondary Outcomes (4)

  • Sleep duration by day

    14 days

  • Number of awake between 10 p.m to 5 a.m

    14 days

  • Anxiety by the COVI scale

    14 days

  • Behavioral disorders by the NPI scale

    14 days

Study Arms (1)

Light therapy

OTHER

Innovative ambient lighting

Device: Light therapy

Interventions

Light therapyDEVICE

14-days exposure with an innovative ambient light

Light therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Residents refusing to lend to experimentation
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EHPAD ORPEA Valenton

Valenton, 94460, France

Location

MeSH Terms

Interventions

Phototherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 12, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

FR(1)