A feasibility trial comparing a behavioural intervention, melatonin and usual care for people with dementia and sleep disturbance

INTERVENTION: Arm 1: Melatonin: People allocated to the melatonin intervention will be provided with melatonin which will be sourced from compounding pharmacies. We will provide a low dose (3mg), non‐sustained release preparation. Participants will be asked to take the melatonin one hour before the desired bedtime with a small amount of water. Melatonin will be taken daily for 8 weeks. Arm 2: Behavioural intervention: Participants receiving the behavioural intervention will receive four consultations with an occupational therapist. The occupational therapist will problem solve with the carer to develop a management plan incorporating sleep hygiene advice. The four consultations lasting up to one hour will be provided over a maximum of a 4 week period. The first consultation will take place in the home and remaining consultations may take place in the home or over the phone depending on client needs. Treatment records written by the occupational therapist will be used to examine adherence to the intervention protocol and to describe the intervention provided. Additional fidelity checks will not be undertaken. CONDITION: Sleep disturbance dementia PRIMARY OUTCOME: Activity measured using an activity monitoring system (fitbit device) which will be worn on the persons wrist and provides information about activity during the day as well as rest and sleep patterns. SECONDARY OUTCOME: Caregiver burden measured using the Zarit Burden Interview. Completed by the caregiver. Geriatric Depression Scale Insomnia severity index completed by the participant OSA50 questionnaire measuring risk of sleep apnea (completed by the participant in conjunction with the carer). Sleep diary (measuring time in bed, lights out, asleep, waking and out of bed) which will be completed by the carer objective screening for OSA with ApneaLink (outcome is presence of OSA or not). INCLUSION CRITERIA: ‐ Diagnosis of dementia provided by a medical practitioner (GP or specialist) ‐ MMSE score of less than 24/30 ‐ Must be aged 21 years or older and speak fluent English ‐ Lives in a private dwelling with a carer ‐ One or more sleep problems on the Sleep Disorders Inventory ‐ No contraindications to taking melatonin (assessed by the treating medical team at the hospital)