Contact information
Type
Scientific
Primary contact
Dr Iracema Leroi
ORCID ID
Contact details
Park House
North Manchester General Hospital
Delaunay's Road
Crumpsall
Manchester
M8 5RB
United Kingdom
+44 (0)161 720 2497
ILeroi2002@yahoo.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3
Study information
Scientific title
Acronym
Study hypothesis
By managing sleep disturbance in PD sufferers, we will significantly enhance quality of life in carers of PD sufferers.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Parkinson's disease
Intervention
Behavioural intervention (a sleep hygiene education program) versus a placebo intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 outcome measures
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 Parkinsons Disease Rating Scale, subscore (UPDRS- motor) & the Hoehn-Yahr Scale (HYS) for stage of motor severity in PD).
Overall trial start date
01/07/2005
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of Parkinsons 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15 patient-carer pairs (30 in total)
Participant 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
Recruitment start date
01/07/2005
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Park House
Manchester
M8 5RB
United Kingdom
Sponsor information
Organisation
Manchester Mental Health and Social Care Trust (UK)
Sponsor details
Chorlton House
70
Manchester Road
Chorlton
Manchester
M21 9UN
United Kingdom
+44 (0)161 882 1138
stephanie.burns@mhsc.manchester.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
No funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20157905
Publication citations
-
Results
Leroi I, Baker P, Kehoe P, Daniel E, Byrne EJ, A pilot randomized controlled trial of sleep therapy in Parkinson's disease: effect on patients and caregivers., Int J Geriatr Psychiatry, 2010, 25, 10, 1073-1079, doi: 10.1002/gps.2472.