ISRCTN ISRCTN87743899
DOI https://doi.org/10.1186/ISRCTN87743899
Secondary identifying numbers N0388179219
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
31/08/2012
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Alice Theadom
Scientific

The Hillingdon Hospital NHS Trust
Pield Health Road
Uxbridge
UB8 3NN
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Fibromyalgia
InterventionCurrent 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 typeOther
Primary outcome measureTo improve sleep quality and quality of life of patients with fibromyalgia syndrome.
Secondary outcome measuresIncreased understanding of the association between sleep, pain and fatigue
Overall study start date01/07/2006
Completion date01/01/2009
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients with fibromyalgia.
Key exclusion criteria1. Sleep disorder
2. Change in medical treatment in the last 3 months
3. No experience of sleep difficulties
Date of first enrolment01/07/2006
Date of final enrolment01/01/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Hillingdon Hospital NHS Trust
Uxbridge
UB8 3NN
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Hillingdon Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan