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Study terminated/withdrawn due to the prolonged timeline since initial ethical approval (without starting) and the number of significant changes to the management and structure of the study deemed appropriate for continuation due to the delays.
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This is an observational, controlled, single-centre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for disproportionate breathlessness. The core methodology involves capturing of data during a short period of measurement of breathing using SLP.
Cohort A: This study is a pilot study with four study visits (Screening, Baseline, week 13 and week 26) to generate data to characterise the tidal breathing patterns and parameters with Thora3Di™. Subjects will have a screening visit within 0 to 14 days prior to the first study visit. For each study visit, subjects will be seen in the clinical research facility and have two 5-minute SLP measurements (at rest and on exertion). The SLP measurement should be performed prior to standard lung function tests with minimal impact on clinical time and not change to hospital attendance. Also, each visit subjects will be asked to report concomitant medications and adverse events, and fill several questionnaires forms as outlined in the SOAs.
Cohort B: Healthy subjects will have only one visit for this study. After signing the informed consent form, subjects will undergo two 5-minutes SLP measurements (at rest and on exertion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysfunctional Breathing | Patients with Dysfunctional breathing age between 16 to 75 will be included. |
| |
| Healthy Volunteers | Healthy Volunteers without any respiratory problems age between 16 to 75 will be included. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thora3DiTM | Device | Not international |
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| Measure | Description | Time Frame |
|---|---|---|
| Estabilsih expected value and dispersion of Structured Light Phlethysmography in Dysfunctional breathing patients | Measure SLP parameters during the course of the treatment : Baseline, Week 13 and Week 26 at rest and at exertion | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Establish a relationship between Structured Light Phlethysmography parameters and patient report outcomes addressed. | Compare SLP parameters with patient outcome reports (Nijmegen and St George Respiratory Questionnaires and BPAT and BORG scores during the course of the treatment | 26 weeks |
| Establish different SLP parameters between patients with dysfunctional breathing and healthy subjects. |
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Inclusion Criteria:
• Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO).
Exclusion Criteria:
Subject unable to sit in an upright position for required period
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Cohort A: Any adult who is presenting with controlled disproportionate breathlessness will be considered for inclusion as a diseased subject (with excluded comorbidities as cause of breathlessness e.g. uncontrolled asthma (GINA 2019 guidelines), uncontrolled cardiac disease, ILO).
• Cohort B: Any adult who is in good respiratory health will be considered for inclusion as a normal in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Aashish Vyas, MD | Royal Preston Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pneuma Care Ltd | Ely | Cambridgeshire | CB7 4EX | United Kingdom |
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Compare the differences in SLP parameters between patients with dysfunctional breathing and healthy subjects |
| 26 weeks |