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
Protocol serial number	RRCC804F res/1808/7002
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Stephen Bourke
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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(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
Key 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
Completion date	10/01/2002

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	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

NHS Northern & Yorkshire Regional Office

Newcastle upon Tyne
NE2 4AB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2006		Yes	No