Condition category
Nervous System Diseases
Date applied
08/09/2005
Date assigned
14/09/2005
Last edited
04/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 Parkinson’s 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 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 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

  1. 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.

Additional files

Editorial Notes