Effects of Light-therapy in Alzheimer's Disease

NCT02686190 | Completed

• 2 other identifiers: P081119IDRCB
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Management of patients with Alzheimer's disease associated with behavioral disturbances is difficult especially in those with agitation/aggression and insomnia and nighttime behaviors. No treatment has shown any efficacy to control these disturbances and psychotropics drugs, i.e. sedatives and hypnotics have numerous adverse effects. Objective: Assess the effect of bright light therapy on behavioral disturbances of patients with Alzheimer's disease, especially the effect on agitation/aggression and insomnia and nighttime behaviours. Study design: Multicenter non pharmacological intervention trial, controlled, randomized, open, two-arm design : control group and intervention group. Centres : Rehabilitation and long term-care units of 4 geriatric hospital wards. Patients: 120 patients admitted in geriatric hospital wards (30 by centre), with probable Alzheimer's disease according to DSM-IV diagnosis criteria and agitation/aggression (associated or not with insomnia or nighttime behaviors) according to the Neuropsychiatric inventory, nurse scale (NPI-nurse). Treatments: Intervention group: patients will participate in a program of bright light therapy realised during a one-hour sessions of occupational therapy,. These sessions will be realised for groups of 6 patients and will be done every week day, at late morning, for 4 consecutive weeks). During the session, patients will be exposed to 10000 lux-bright light. Patients of control group will participate in a program of occupational therapy of same duration and rhythm, realised in standard light conditions (about 300 lux). Assessment: Patients with be assessed on 3 occasions: inclusion, two and four weeks after the beginning of the programs. Assessment will comprise ; NPI-nurse scale and Cohen-Mansfield scale for behaviour disturbances, wrist actimetry for sleep and nighttime behaviours (total sleep length, nocturnal wake episodes and nocturnal motor agitation). Judgment criteria: Principal: changes in the agitation/aggression item of NPI-nurse scale. Secondary: changes of the nightime behaviours item of NPI-nurse scale, the Cohen-Mansfield, total sleep duration and numbers of nocturnal wake episodes measured by wrist actimetry. Statistics: Changes in agitation/aggression scores od the two groups will be compared by Mann and Whitney test. Expected results and perspectives; If bright light exposure is efficient, professional caregivers of Alzheimer's disease patients might apply this cheap and non pharmacological approach to improve behaviour and sleep of these patients. This study might contribute to better define the place of a non invasive and promising technique, wrist actigraphy, to assess sleep and behaviour disturbances in psychogeriatric patients

Conditions

Alzheimer's Disease

Keywords

Alzheimer; luxtherapy, sleep disturbance, behaviour disturbance

Outcome Measures

Primary Outcomes (1)

• score agitation / aggression scale NPI-nurse

  Change over time of the score obtained in item agitation-aggression of the NPI-level nurse.

  Baseline, 2 weeks and 4 weeks

Secondary Outcomes (1)

• score agitation-aggression scale NPI-nurse

  Baseline, 2 weeks and 4 weeks

Other Outcomes (3)

• scale score Cohen-Mansfield

  Baseline, 2 weeks and 4 weeks

• MMSE scale score

  Baseline and 4 weeks

• Nocturnal sleep data measured by wrist actimetry

  Baseline, 2 weeks and 4 weeks

Study Arms (2)

Luxtherapy

EXPERIMENTAL

Luxtherapy exposition

Other: Luxtherapy

Not luxtherapy

NO INTERVENTION

Not luxtherapy exposition

Interventions

Luxtherapy OTHER

Luxtherapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 60 years
• Patient hospitalized in geriatric care immediately or long-term care,
• Patients with probable Alzheimer's disease according to NINCDS-ADRDA
• Stage of moderate to severe Alzheimer's disease (defined as MMSE between 2 and 21).
• Patients with agitation rated 4 or more per item agitation / aggression of the behavior rating scale Neuropsychiatric Inventory-nurse,
• Patient free from acute disease.
• Patient with sleep apnea evaluation scale ONSI (Observation-based nocturnal Sleep Inventory) negative
• Affiliation to a social security scheme
• Signature of consent by the patient himself or the trusted person or legal representative for patients under guardianship

You may not qualify if:

• Patients may leave the ward within 4 weeks
• Patient refusing to participate in the study
• Patient with a trusted person and / or legal representative which refuses participation in the study.
• Patient receiving photosensitizing drug imipramine, lithium, tetracycline, hydrochlorothiazide, phenothiazine.
• Patients suffering from porphyria.
• Patient with known REM sleep behavior disorder
• Patients with clinical criteria of mental confusion as diagnosing clinician.
• Unbalanced psychotropic treatment subject to dose modifications in the previous 4 weeks (patients receiving one or more psychotropic stable dose for at least 3 weeks may be included).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Charles Foix

Ivry-sur-Seine, 94205, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Parasomnias

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders

Study Officials

• Joël BELMIN, PUPH

  00 331 49 59 45 65

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 19, 2016
• Study Start: July 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 17, 2016

Record last verified: 2016-02

Locations

FR (1)