A parallel multi-centre randomised controlled trial to determine the clinical and cost-effectiveness of DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people living with dementia and their carers

Not Applicable

• Conditions: Sleep disturbance in people with dementia; Nervous System Diseases

• Registration Number: ISRCTN13072268
• Lead Sponsor: Camden and Islington NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38307536/ (added 09/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-30
• Last Update Posted: 19 February 2024
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

1. People with dementia (any type/ severity/ on any or no medication)
2. Sleep Disorders Inventory (SDI) score >=4. The SDI is a valid and reliable standalone tool for sleep disorder in people with dementia. Those who score >=4 have clinically significant sleep disorder
3. Sleep that patient or their family judge as problematic
4. Patient with capacity gives consent, or if not capacitous, consultee gives consent and patient not unwilling
5. Family carer gives informed consent
6. Family carer supports the person with dementia emotionally or practically at least weekly
7. Person with dementia lives in their own home with someone present at night

Exclusion Criteria

Current exclusion criteria as of 18/12/2023:
1. Known primary sleep breathing disorder diagnosis preceding dementia (e.g. sleep apnoea) from self or proxy report
2. Current known heavy alcohol use from self or proxy report (AUDIT C Score >=8)
3. People unavailable for >3 weeks of intervention and follow-up (e.g. planned holiday or hospital admission
4. Currently enrolled in another non pharmacological dementia RCT
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Previous exclusion criteria:
1. Known primary sleep breathing disorder diagnosis preceding dementia (e.g. sleep apnoea) from self or proxy report
2. Current known heavy alcohol use from self or proxy report (AUDIT C Score >=5)
3. People unavailable for >3 weeks of intervention and follow-up (e.g. planned holiday or hospital admission
4. Currently enrolled in another non pharmacological dementia RCT

Study & Design

• Study Type: Interventional
• Study Design: Not specified