A pilot study of a sleep hygiene education program in Parkinson’s disease s... | Not Recruiting
A pilot study of a sleep hygiene ed... | Not Recruiting
A pilot study of a sleep hygiene education program in Parkinson’s disease sufferers: effect on carer well-being

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Medical Conditions
  • Parkinson's disease
Primary Contact Details
Dr Iracema Leroi
+44 (0)161 720 2497
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN11720842
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Not provided at time of registration
Research Details
  • By managing sleep disturbance in PD sufferers, we will significantly enhance quality of life in carers of PD sufferers.
Phase
Not Applicable
Study Design
Randomised controlled trial
Study Type
Interventional
Intervention

Behavioural intervention (a sleep hygiene education program) versus a placebo intervention.

Intervention Type
Other
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 Parkinson’s Disease Rating Scale, subscore (UPDRS- motor) & the Hoehn-Yahr Scale (HYS) for stage of motor severity in PD).
Publication(s)
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20157905
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
15 patient-carer pairs (30 in total)
Participant 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
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
Lancashire
M8 5RB
Trial Contact(s)
Primary Trial Contact
Dr Iracema Leroi
+44 (0)161 720 2497
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Sorry, this information is not available
EudraCT Number
Sorry, this information is not available
Funder(s)
  • No funding
Other Study ID Numbers
3
Sponsor(s)
Manchester Mental Health and Social Care Trust (UK)
Key Dates

Recruitment Start Date

01 Jul 2005

Recruitment End Date

01 Jan 2006

Trial Start Date

01 Jul 2005

Trial End Date

01 Jan 2006

Date added to source

14 Sep 2005

Date updated in source

04 Mar 2013