Effect of light treatment on sleep and behavior in patients with Alzheimer`s disease

Not Applicable

Completed

Conditions: Mental and behavioral disorders

Registration Number: KCT0005282

Lead Sponsor: Kangwon National University

Brief Summary: Sleep and behavioral disturbances are prevalent in patients with Alzheimer`s disease (AD), burdening distress for their caregivers. A non-pharmacological treatment is required to improve sleep and behavioral disturbances in AD patients, who are often more vulnerable to the adverse effects of pharmacologic agents. We aimed to examine the effect of timed blue-enriched light on the sleep and behavior in AD patients, and the relationship of its effect on the sleep and behavior with changes in the circadian rhythm Each patient was assessed three times (T0=before timed LBA; T1=immediately after timed LBA; T2= 4 weeks after timed LBA) with the questionnaires and actigraphy. In the laboratory, the dim light melatonin onset (DLMO) was determined from seven hourly saliva samples obtained starting from 6 hours prior to sleep onset measured by actigraphy. At home, 1-h blue enriched LT for 2 weeks was applied between 9 to 10 h after the DLMO for each patient. The CG subjects were kept to wear blue-blocked glasses during timed LT. Twenty-three patients (78.3±5.7years) of TG and 16 patients (79.0±6.6years) of CG were included in the final analysis. TG had significantly improved subjective sleep quality and showed a tendency toward improved neuropsychiatric symptoms and depressive symptoms after timed LBA. We found the acrophase of the sleep-wake rhythm in the TG was about 30 minutes earlier after timed LBA, while there were no significant changes in the sleep-wake rhythm and light exposure rhythm after timed LBA in the TG and CG. We also showed a possibility that the caregiver burden would be improved after timed LT. Previous studies have applied light treatment without considering individual circadian rhythm in AD patients. As a result, there was a limit to interpret its outcome. It is meaningful that we have determined the proper timing of light box apply based on the DLMO, illustrating the efficacy of timed LBA on sleep and behavior in AD patients, for the first time.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 39

Inclusion Criteria

Patient eligibility criteria included a diagnosis of probable or possible AD for major neurocognitive disorder, a CDR score ranging from 0.5 to 2, a sleep disturbance verified by a score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI) 25 and/or by one or more complaints among difficulty initiating sleep (DIS), difficulty maintaining sleep (DMS), and early morning awakening (EMA) for three or more days per week.

Exclusion Criteria

1) current substance related disorders, depressive disorders, or other psychiatric disorders by DSM-5; 2) current medical illness including liver cirrhosis, chronic pulmonary disease, cancer, uncontrolled diabetes, and uncontrolled hypertension; 3) being suspected or diagnosed with primary sleep disorders except for insomnia disorder (i.e., restless legs syndrome, sleep-disordered breathing disorder; hypersomnia, or narcolepsy); 4) a prior history of cerebrovascular disease or central nervous system (CNS) disease, or evidence of CNS injury; 5) current use of any medication affecting their circadian rhythms (i.e., CircadinR); 6) changes in type or dose of taking hypnotics or CNS active drugs for the study period; 7) significant impairment of hearing ability, visual acuity, or language ability which hindered the completion of neurocognitive tests; 8) abnormalities in complete blood cell count, liver function test, urine analysis, electrocardiogram (ECG), or chest X-ray; AND 9) pupillary abnormalities on a neuro-ophthalmological examination.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) Subjective sleep quality (Pittsburgh Sleep Quality Index), (2) Cognitive function (Mini-Mental State Examination in the Korean version of the CERAD assessment packet, Trail making test, Stroop Test, Digit Span Test, Visual Analog Scale), (3) Actigaphy measurements ( sleep parameters, sleep-wake rhythms, light exposure rhythms), (4) Korean version of Cornell Scale for Depression in Dementia, (5) Korean version of Neuropsychiatric Inventory,Korean version of Zarit Burden Interview

Secondary Outcome Measures