Condition category
Musculoskeletal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
31/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Alice Theadom

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes