Effects of Light-therapy in Alzheimer's Disease (ALZ-Light)
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|ClinicalTrials.gov Identifier: NCT02686190|
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : March 17, 2016
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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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Other: Luxtherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Bright Light to Improve Agitation and Sleep Disorders in Patients With Alzheimer's Disease|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||December 2014|
No Intervention: Not luxtherapy
Not luxtherapy exposition
- score agitation / aggression scale NPI-nurse [ Time Frame: Baseline, 2 weeks and 4 weeks ]Change over time of the score obtained in item agitation-aggression of the NPI-level nurse.
- score agitation-aggression scale NPI-nurse [ Time Frame: Baseline, 2 weeks and 4 weeks ]Change over time score to item nocturnal sleep-behavior of the NPI-nurse
- scale score Cohen-Mansfield [ Time Frame: Baseline, 2 weeks and 4 weeks ]Change over time in the Cohen-Mansfield scale
- MMSE scale score [ Time Frame: Baseline and 4 weeks ]Change over time score scale MMSE
- Nocturnal sleep data measured by wrist actimetry [ Time Frame: Baseline, 2 weeks and 4 weeks ]
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|Ages Eligible for Study:||60 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
- Patients suffering from retinopathy (DMLA, proliferative diabetic retinopathy) or blindness for whatever reason, lack of crystalline (or aphakia). (These conditions will be systematically sought by an ophthalmologic consultation if the patient has not had in the year before inclusion.)
- Patient receiving photosensitizing drug imipramine, lithium, tetracycline, hydrochlorothiazide, phenothiazine.
- Patients suffering from porphyria.
- Patient with known sleep apnea syndrome. (A specific test for the detection of sleep apnea will be checked prior to the inclusion of patients. This is the test ONSI, validated in elderly demented persons, and allowing screened for sleep apnea in patients with a sensitivity of 91%. ONSI positive test will be an exclusion criteria of the study.)
- Patient with known REM sleep behavior disorder
- Patients with clinical criteria of mental confusion as diagnosing clinician.
- Patient with obvious pathology may itself cause behavior disorders: psychosis, manic-depressive illness, a condition with acute or chronic pain. (In these cases, the inclusion of the patient may be reviewed after returning to a stable clinical condition for at least 3 weeks.)
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686190
|Hôpital Charles Foix|
|Ivry-sur-Seine, France, 94205|
|Principal Investigator:||Joël BELMIN, PUPH||00 331 49 59 45 65|
|Responsible Party:||Assistance Publique - Hôpitaux de Paris|
|Other Study ID Numbers:||
IDRCB ( Other Identifier: 2011-A01601-40 )
|First Posted:||February 19, 2016 Key Record Dates|
|Last Update Posted:||March 17, 2016|
|Last Verified:||February 2016|
Alzheimer; luxtherapy, sleep disturbance, behaviour disturbance
Central Nervous System Diseases
Nervous System Diseases