Sleep disturbance in people with dementia Nervous System Diseases
Conditions
Interventions
Current interventions as of 16/01/2024:
Design
A multi-centre randomised controlled trial, with qualitative process evaluation. Participants (both family carers and people living with dementia) will
Sponsors
Camden and Islington NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 _____ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resident sleep at 8 months measured using the SDI | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline, 4 month and 8 month follow ups: Person living with dementia (all proxy measures): 1. Neuropsychiatric symptoms (Neuropsychiatric Inventory, NPI) 2. Tendency to sleep/doze in specific daytime situations (Epworth sleepiness scale (ESS)) 3. Quality of life (DEMQOL-Proxy) answered by a carer. This will also be used in the cost-effectiveness analysis to calculate Quality of life Adjusted Life Years (QALY) 4. Modified Client Service Receipt Inventory (CSRI) a proxy questionnaire asking about health and social care service use information in the past 4 months for the patient (including care home admission, extra patient care during therapy) 5. EQ-5D 5 level (EQ-5D-5L) proxy is a generic measure of health-related quality of life. Carer proxy responses will be used to calculate QALYs and incremental cost per QALY gained 6. Medication- psychotropic medication to delineate the role of rescue medication and any effect of the intervention on prescribing. This data will be collected as part of the CSRI 7. Side effects measure for fall and comorbidities at baseline. Using a Safety, and Tolerability Assessment to record the occurrence of falls, dizziness, headaches and gastrointestinal symptoms (appetite or bowel symptoms) and other side effects and whether these were mild, moderate or severe. This will allow us to assess potential harms 8. One-week actigraphy for person with dementia (Axivity AX3 from baseline and before 4 and 8-month follow-up) Family carer: 1. Sleep Condition Indicator (SCI) is an eight item scale to assess sleep disturbance 2. The hospital anxiety and depression scale (HADS) is a validated, reliable instrument to measure mood throughout age groups 3. Zarit Burden Interview (ZBI) the most commonly used and well validated measure of burden for carers of people with dementia 4. Health Status Questionnaire (HSQ-12) a 12-item health-related quality of life scale validated throughout age groups 5. Modified Client Service Receipt Inventory (CSRI) a q | — |
Countries
England, United Kingdom
Outcome results
None listed