Topic: Dementias and Neurodegenerative Diseases Research Network
Conditions
Interventions
CoughAssist® mechanical in-exsufflator versus breath stacking technique.
Study entry: single randomisation only
Sponsors
Sheffield Teaching Hospitals NHS Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient should not have any serious medical problems, apart from MND, which may reduce life expectancy 2. The patient should be capable of giving informed consent and should not have evidence of any significant impairment of cognitive function 3. Patients with MND in respiratory failure meeting two of the following criteria indicating the need for NIV: 3.1. Nocturnal or daytime hypercapnia (arterial blood gas [ABG] partial pressure of carbon dioxide in the blood [PaCO2] greater than 6.0 kPa) 3.2. Nocturnal hypoxaemia (oxygen saturation [SaO2] less than 88% for 5 consecutive minutes of the time asleep) 3.3. Lung function tests - forced vital capacity (FVC) less than 60% predicted 3.4. Maximal expiratory pressure less than 60 cm H2O 3.5. Orthopnoea 3.6. Symptoms of hypersomnolence or non-refreshing sleep 4. The patient should have a main carer who is willing to assist the patient in following the treatment regimen 5. The patient must fulfill the El Escorial clinically or laboratory supported probable or definite criteria for MND
Exclusion criteria
Exclusion criteria: 1. Inability to tolerate NIV 2. Infringement of the contraindications of CoughAssist® (a history of bullous emphysema, susceptibility to pneumothorax or pneumo-mediastinum, or recent baratrauma) 3. Presence of a significant medical condition, other than MND, which may reduce life expectancy 4. Presence of significant impairment of cognitive function (for example, clinically overt fronto-temporal dysfunction which is clinically evident and noticeable to the family) 5. Participation in any other interventional trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days with symptoms of chest infections requiring antibiotic therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of days in as a hospital inpatient due to chest infection 2. Quality of life (36-item short form health survey [SF-36]) | — |
Countries
United Kingdom
Outcome results
None listed