Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
Behavioural intervention (a sleep hygiene education program) versus a placebo intervention.
Sponsors
Manchester Mental Health and Social Care Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Parkinson?s disease (based on UK Brain Bank Criteria) in the mild-moderate stage (Hoehn-Yahr rating <4) 2. Men and women between the ages of 35 and 90 3. Sleep disturbance in the PD sufferer, as determined by screening sleep questionnaire 4. PD sufferer has a live-in carer who is willing to participate in the study 5. Good general physical health or stable medical condition 6. Able to give consent and willing to participate in the study 7. Mini-mental State Examination (MMSE) score of <27 in the PD participant
Exclusion criteria
Exclusion criteria: 1. Dementia or severe psychiatric disturbances which would render them unable to participate with study procedures 2. Severe, unstable medical conditions 3. Those unable to give their own consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in overall carer well-being as measured by the General Health Questionnaire (GHQ). This is a well-established and well-validated measure of general physical and mental well being. 2. Change in overall carer burden as measured by the Burden Interview. This is a well-established and well-validated measure of feelings of burden of caregivers in caring for an older person with dementia. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sleep disturbance in carers/sufferers (Epworth Sleepiness Scale & sleep diary) 2. Quality of life in PD sufferers (PD-QOL, a quality of life scale) 3. Psychiatric/behavioural functioning in sufferers/carers (Geriatric Depression Scale, & Neuropsychiatric Inventory/NPI carer distress scale (NPI). 4. Parkinsonian motor symptoms in PD sufferers (Unified Parkinson?s Disease Rating Scale, subscore (UPDRS- motor) & the Hoehn-Yahr Scale (HYS) for stage of motor severity in PD). | — |
Countries
United Kingdom
Outcome results
None listed