Sleep disordered breathing and the impact of nocturnal non-invasive ventilatory support on quality of life in motor neurone disease
| ISRCTN | ISRCTN76330611 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76330611 |
| Secondary identifying numbers | RRCC804F res/1808/7002 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stephen Bourke
Scientific
Scientific
NHS Northern & Yorkshire Regional Office
Postgraduate Institute South Tyneside
10-12 Framlington Place
Newcastle upon Tyne
NE2 4AB
United Kingdom
| Phone | +44 0191 284 311 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous system diseases: motor neurone disease |
| Intervention | 1. Early intervention with non-invasive ventilation 2. Standard care |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 10/01/2000 |
| Completion date | 10/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Added December 2008: 102 |
| Key inclusion criteria | Patients with motor neurone disease under 75 years of age and without other serious illnesses. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/01/2000 |
| Date of final enrolment | 10/01/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NHS Northern & Yorkshire Regional Office
Newcastle upon Tyne
NE2 4AB
United Kingdom
NE2 4AB
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2006 | Yes | No |
