Methods |
RCT |
Participants |
Inclusion criteria:
participants aged > 60 years with existing physician diagnosis of Alzheimer's disease‐related dementias or self‐reported memory impairment and a score of ≥ 0.5 on Clinical Dementia Rating Scale
presence of sleep problems determined first during telephone screening using Neuropsychiatric Inventory sleep disorders item, then using proxy‐rated Sleep Disorders Inventory
stable dose of psychotropic medications, sedatives/hypnotics, antidementia medication, or opioids in the past 90 days
tolerates and agrees to wear wrist actigraph
responsive to their environment (e.g. able to understand short commands)
sufficient English language skills to complete questionnaires
Exclusion criteria:
planned transition to another residential or institutional care setting in < 3 months to decrease attrition rates
hearing impairment (defined as inability to hear a normal speaking voice at a distance of (quote) "1–1/2 feet") to exclude those who cannot hear the music intervention
presence of extrapyramidal symptoms affecting non‐dominant hand which may include people with the following diagnoses: schizophrenia, bipolar disorder, Huntington's disease, Parkinson's disease, Lewy Body dementia due to rapid eye movement sleep disorders affecting actigraphy measurement of sleep disruption
currently enrolled in an interventional clinical trial for Alzheimer's disease‐related dementias aimed to improve sleep to avoid confounding the efficacy results
acute sleep disruption within 2 weeks of screening as it may indicate sleep disorders not related to Alzheimer's disease‐related dementias or delirium
end‐stage disease (i.e. cancer, bed‐bound) to minimise factors affecting actigraphy measurement
|
Interventions |
Listening to tailored calming music at bedtime for 30 minutes every night for 4 weeks (28 sessions total), provided by a carer |
Outcomes |
Feasibility and acceptability study, sleep latency, wake after sleep onset, total sleep duration, sleep diary, Neuropsychiatric Inventory sleep item, PROMIS sleep‐related impairment version SF 8a, sleep disorder inventory |
Notes |
Results will not be published until second half of 2022. |