CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 744 enrolled
Drug / intervention
N-Tidal C handsetdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04939558
NCT04939558N/ACompleted
CompareCT.gov

A Longitudinal Observational Study to Investigate the Patterns of Change in the Tidal Breathing CO2 Waveform, Measured Using the N-Tidal C Handset, in Patients With COPD Compared to Patients With Other Common Cardiorespiratory Conditions

TidalSense·observational·Posted Jun 25, 2021·Updated Jun 2, 2023

In Brief

An observational study evaluating N-Tidal C handset for COPD and 9 related conditions. Completed, enrolled 744 participants across 1 site.

Detailed Summary

This study uses a new breathing device called 'N-Tidal C' handset which measures breathing patterns. Investigators have found that people with cardiac and respiratory illnesses breathe out a gas, called carbon dioxide (CO2), in a different way to healthy people. The pattern of breathed out CO2 (the waveform) varies according to the underlying health of the user's lungs. Monitoring these changes may help doctors to more accurately diagnose and monitor the most common and serious respiratory conditions.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD, Asthma, Lung Cancer, Anemia, Congestive Cardiac Failure, Bronchiectasis, Interstitial Lung Disease, Long COVID, Upper Respiratory Disease, Healthy
CountriesUnited Kingdom
CollaboratorsInnovate UK, National Institute for Health Research, United Kingdom

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 25, 2021
Enrollment StartJun 2, 2021
Primary CompletionNov 2, 2022
Study CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.0 years ago

Interventions

N-Tidal C handsetdevice

Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.