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

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000056392
Acronym
None
Enrollment
30
Registered
2017-01-11
Start date
2018-01-15
Completion date
2019-01-30
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

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

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026