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

Polypathology and Autonomy Loss Clinical Trial

— SOLEIL SOMMEIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829892
• Other study ID #: 14-PP-16
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: July 8, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dementia
• Polypathology and Autonomy Loss

Intervention

Device:
• Light therapy
14-days exposure with an innovative ambient light

Locations

Country	Name	City	State
France	EHPAD ORPEA Valenton	Valenton

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep duration between 10 p.m to 5 a.m		14 days	No
Secondary	Sleep duration by day		14 days	No
Secondary	Number of awake between 10 p.m to 5 a.m		14 days	No
Secondary	Anxiety by the COVI scale		14 days	No
Secondary	Behavioral disorders by the NPI scale		14 days	No