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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN76330611 |
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Date of registration:
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23/01/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sleep disordered breathing and the impact of nocturnal non-invasive ventilatory support on quality of life in motor neurone disease
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Scientific title:
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Date of first enrolment:
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10/01/2000 |
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Target sample size:
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102 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN76330611 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Stephen
Bourke |
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Address:
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NHS Northern & Yorkshire Regional Office
Postgraduate Institute South Tyneside
10-12 Framlington Place
NE2 4AB
Newcastle upon Tyne
United Kingdom |
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Telephone:
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+44 0191 284 311 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with motor neurone disease under 75 years of age and without other serious illnesses.
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Nervous system diseases: motor neurone disease
Nervous System Diseases
Motor neurone disease
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Intervention(s)
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1. Early intervention with non-invasive ventilation
2. Standard care
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Secondary ID(s)
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RRCC804F res/1808/7002
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Source(s) of Monetary Support
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NHS Executive Northern and Yorkshire (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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