|
ISRCTN
|
ISRCTN76330611
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Sleep disordered breathing and the impact of nocturnal non-invasive ventilatory support on quality of life in motor neurone disease
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
RRCC804F res/1808/7002
|
|
Study hypothesis
|
1. Early intervention with non-invasive ventilation will improve quality of life, survival and respiratory function in patients with motor neurone disease.
2. Domiciliary non-invasive ventilation in patients with motor neurone disease will not increase the stain experienced by the primary carer.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Nervous system diseases: motor neurone disease
|
|
Participants - inclusion criteria
|
Patients with motor neurone disease under 75 years of age and without other serious illnesses.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
10/01/2000
|
|
Anticipated end date
|
10/01/2002
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Added December 2008: 102
|
|
Interventions
|
1. Early intervention with non-invasive ventilation
2. Standard care
|
|
Primary outcome measure(s)
|
Quality of life
1. Generic instrument: Short Form 36
2. Specific instruments: Chronic Respiratory Disease Index, Sleep Apnoea Quality of Life Index, Epworth Sleepiness Scale
|
|
Secondary outcome measure(s)
|
1. Survival
2. Impact on primary carer: Care Givers Strain Index
3. Hospital admissions
4. Respiratory function: Vital capacity, maximum static mouth pressures, sniff nasal inspiratory pressure
|
|
Sources of funding
|
NHS Executive Northern and Yorkshire (UK)
|
|
Trial website
|
|
|
Publications
|
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16426990
|
|
Contact name
|
Dr
Stephen
Bourke
|
|
Address
|
NHS Northern & Yorkshire Regional Office
Postgraduate Institute South Tyneside
10-12 Framlington Place
|
|
City/town
|
Newcastle upon Tyne
|
|
Zip/Postcode
|
NE2 4AB
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 0191 284 311
|
|
Email
|
|
|
Sponsor
|
NHS R&D Regional Programme Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
23/01/2004
|
|
Last edited
|
08/12/2008
|
|
Date ISRCTN assigned
|
23/01/2004
|
