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OpenTrials
Completed

NCT Number: NCT02829892

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EHPAD ORPEA Valenton

Valenton, 94460, France

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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Light Therapy

Device

14-days exposure with an innovative ambient light

Primary outcomes

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

    Time frame: 14 days

Secondary outcomes

  1. Sleep duration by day

    Time frame: 14 days

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

    Time frame: 14 days

  3. Anxiety by the COVI scale

    Time frame: 14 days

  4. Behavioral disorders by the NPI scale

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: SOLEIL SOMMEIL

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 12, 2016
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.