Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0388179219
Study information
Scientific title
Acronym
Study hypothesis
To explore whether a sleep intervention tailored to people's individual needs can improve sleep quality and quality of life in patients with fibromyalgia.
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
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Musculoskeletal Diseases: Fibromyalgia
Intervention
Current practice vs current practice and psychological intervention.
2 groups: a treatment group and an intervention group.
31/08/2012: Please note that this trial was abandoned before starting due to a lack of funding.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
To improve sleep quality and quality of life of patients with fibromyalgia syndrome.
Secondary outcome measures
Increased understanding of the association between sleep, pain and fatigue
Overall trial start date
01/07/2006
Overall trial end date
01/01/2009
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
Patients with fibromyalgia.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Sleep disorder
2. Change in medical treatment in the last 3 months
3. No experience of sleep difficulties
Recruitment start date
01/07/2006
Recruitment end date
01/01/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Hillingdon Hospital NHS Trust
Uxbridge
UB8 3NN
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Hillingdon Hospital NHS Trust (UK)
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