None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (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
| Measure | Time frame |
|---|---|
| (1) Korean version of Epworth Sleepiness Scale, (2) Activities of Daily Living, (3) Korean version of the Geriatric Depression Scale | — |
Countries
Korea, Republic of
Contacts
Kangwon National University Hospital