ClinicalTrials.gg
CompletedNCT03356288GBRSUpdated Sep 20, 2018

The General Breathing Record Study

An observational study in Asthma, Heart Failure and Pneumonia, sponsored by TidalSense. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-20.

Sponsored by TidalSense · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
16 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 558 studies in Asthma with a site in United Kingdom — 52 open to participants now, 72 under way, 11 of them phase 3. Asthma · United Kingdom.

Enrollment
94th of 131
70 · median 149
Started
2017
with 37 others
Observational
131 of 558
24 open now
Registered
348th of 558
by date

Among the 558 studies in Asthma with a site in United Kingdom, this one is the 94th largest by enrollment of the 131 observational ones that give a count, is one of 38 that started in 2017, is one of 131 observational ones, and was the 348th registered.

Asthma

4,843 studies on the registry are indexed under Asthma; 602 are open to participants now.

Browse Asthma studies →

Open to participants now

52 of the 558 studies in Asthma with a site in United Kingdom are open now. Recruiting first, the newest first:

47 more — sign in →

All 52 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.

This study: 16 Years and older · all sexes · healthy volunteers too.

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02

Study summary

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.

Read the detailed description

When a person breathes out, they exhale carbon dioxide (CO2). The CO2 levels in breath change as they breathe out and this makes a specific pattern, or "waveform". This waveform can tell a clinician a lot about the underlying health of a person. There are disease specific CO2 waveforms for common breathing conditions such as Asthma and Chronic Obstructive Pulmonary Disease (COPD). However up until this point there has been no accurate and non-invasive method of measuring the tidal breath CO2 waveform.

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.

03

Conditions studied

  • Asthma
  • Heart Failure
  • Pneumonia
  • Motor Neuron Disease
  • Vocal Cord Dysfunction
  • Breathlessness

Keywords

  • Capnography, Diagnosis. Breathlessness, Exacerbations, Device
04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The healthy Cohort will be made up of healthy volunteers. The Disease Cohorts will be selected from hospital outpatient clinic lists and inpatient wards.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Asthma Cohort:

  • 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 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 \<40% on most recent imaging within the last 12 months.
    2. 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.

Pneumonia Cohort:

  • A confirmed clinical diagnosis of Pneumonia supported by evidence of consolidation on a chest X-ray (CXR) or computed tomography (CT) imaging.

Healthy Cohort:

  • 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 of less than 40. A Non-smoker, or an ex-smoker with less than a 5 pack year history.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • Asthma

    20 Participants with moderate to severe asthma, as defined by British Thoracic Society (BTS) guidelines

  • Chronic heart failure

    10 Participants with a diagnosis of chronic heart failure

  • Breathing Pattern Disorder

    10 Participants with a diagnosis of Breathing Pattern Disorder

  • Pneumonia

    10 participants with a radiologically confirmed diagnosis of pneumonia

  • Motor Neurone Disease

    10 participants with a diagnosis of motor neurone disease with known hypercapnic failure.

  • Healthy

    10 Participants who have no known lung, cardiac or neuromuscular condition.

06

What researchers measure

Primary outcomes

  1. The tidal breathing carbon dioxide waveform for each of the breathing conditions as measured by the N-Tidal C device

    Time frame: 12 months

Secondary outcomes

  1. Change in the Tidal Breathing carbon dioxide waveform over time

    Change in the tidal breathing carbon dioxide waveform, in each disease, over the 6 months.

    Time frame: Change measures - baseline to 6 months

  2. Disease Control in asthma patients

    The Asthma Control Questionnaire Score for the Asthma patients

    Time frame: 12 months

  3. Disease Improvement in Breathing Pattern Disorder patients

    The Nijmegen Questionnaire Score

    Time frame: 12 months

  4. Disease severity in the pneumonia patients

    The CURB-65 Score

    Time frame: 2 days

  5. Disease severity in heart failure patients

    The Trans Thoracic Echocardiogram (TTE) result

    Time frame: 12 months

  6. Hypercapnia in the motor neurone disease patients

    The level of partial pressure carbon dioxide (pCO2)

    Time frame: 12 months

  7. Usability of the N-Tidal C device

    Measured by how frequently the patients remember to use the N-Tidal C device over 6 months

    Time frame: Change measures - baseline to 6 months

  8. Acceptability of the N-Tidal C device

    Measured by a questionnaire of the participants experience of the device at the end of the study

    Time frame: 12 months

07

Study locations

1 site
  • Portsmouth Hospitals NHS Trust
    Portsmouth, Hampshire PO6 3LY, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Jul 2018, 10 months.

Of 90 industry-sponsored observational studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's 10 months is below that.

Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2017
First posted
Nov 29, 2017
StartActual
Aug 9, 2017
Primary completionActual
Jul 4, 2018
CompletionActual
Jul 4, 2018
Last update
Sep 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03356288
Lead sponsor
TidalSense
Collaborators
Innovate UK
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Aug 9, 2017
Primary completion
Jul 4, 2018
Completion
Jul 4, 2018
Last update
Sep 20, 2018

Study contacts

Anoop J Chauhan, PhD
principal investigator · Portsmouth Hospitals NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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