Study Purpose:This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness. It will also evaluate whether this device can detect when a person's breathing problem is getting worse.
Asthma , Heart Failure , Pneumonia , Motor Neuron Disease , Vocal Cord Dysfunction , Breathlessness
Type of Intervention:
Study Chair(s)/Principal Investigator(s):
Anoop J Chauhan, PhD, Portsmouth Hospitals NHS Trust
Coordinating Center Contact Information
Full Study Summary:
This study will test the N-Tidal C, a new handheld device that accurately measures this waveform, and whether it can differentiate different causes of breathlessness; namely asthma, heart failure, pneumonia, breathing pattern disorders and motor neurone disease.
Cambridge Respiratory Innovations Limited
Estimated Study Start Date:
08 / 09 / 2017
Estimated Study Completion Date:
07 / 04 / 2018
Posting Last Modified Date:
09 / 20 / 2018
Date Study Added to neals.org:
11 / 29 / 2017
- A confirmed clinical diagnosis of asthma for ≥ 6months
- Moderate to severe asthma defined as British Thoracic Society stages 3-5
- 2 or more exacerbations in the previous 12 months with at least 1 exacerbation within the last 6 months.
- Exacerbation free for 2 weeks (defined as no increased dose or course of oral corticosteroids or antibiotics).
Breathing Pattern Disorder Cohort
- A Clinical diagnosis of a Breathing Pattern Disorder (BPD)
Chronic heart failure Cohort:
- A confirmed clinical diagnosis of chronic heart failure with both of the following:
1. A Left Ventricular Ejection Fraction <40% on most recent imaging within the last 12 months.
2. New York Heart Association Class 2-4
- Admitted with an acute decompensation of their heart failure to hospital within the last 6 months
Motor Neurone Disease Cohort:
- A confirmed clinical diagnosis of Motor Neurone Disease
- Forced Vital Capacity (FVC) of less than 60% of predicted, sleep disordered breathing or daytime hypercapnia.
- Established on Home Non-Invasive Ventilation.
- A confirmed clinical diagnosis of Pneumonia supported by evidence of consolidation on a chest X-ray (CXR) or computed tomography (CT) imaging.
- No known history of lung, cardiac or neuromuscular disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung, cardiac or neuromuscular disease). A Body Mass Index of less than 40. A Non-smoker, or an ex-smoker with less than a 5 pack year history.
- Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or Tidal Breath Carbon Dioxide measurements.
- In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently over the course of 6 months.
Portsmouth Hospitals NHS Trust