None listed
Conditions
Brief summary
The aim of this study is to determine the feasibility of running a randomised controlled trial in which participants with dementia and sleep disturbance are randomised to either participation in a behavioural intervention (sleep hygiene program), taking melatonin or usual care.
Interventions
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.
Sponsors
Study design
Eligibility
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)
Exclusion criteria
Life expectancy limited to less than nine months, autoimmune disorder or kidney or liver disease