Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

Study Overview
=================
Brief Summary
-----------------
The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.

Official Title
-----------------
Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

Conditions
-----------------
Breathlessness, COPD, Asthma, Asthma Chronic, Wheezing, Dyspnea, Shortness of Breath

Intervention / Treatment
-----------------
* Other: Biomarker tests for participant profiling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-90 years. Has experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional. Self-reported breathlessness using any of the following words to describe symptoms will qualify as a presentation of breathlessness regardless of aetiology or severity of symptoms: shortness of breath, tight chest, trouble breathing, breathlessness, dyspnoeic, breathless, asthmatic, suffocating, wheezing, fighting for breath or any equivalent word. Breathlessness does not have to be the primary presenting symptom. Deemed clinically sufficiently stable to participate according to health care practitioner. Exclusion Criteria: Inability to understand written local language at a year 5 level. Not being confident in use of digital technology (smartphone and/or tablet). This will become evident through an inability to use the system. Inability to enter required study sample data due to diminished consciousness and/or physical or mental capacity regardless of whether this is associated with the breathlessness event. Received an investigational medical product in the context of a Clinical Trial during the 28 days prior to first probe administration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe Breathlessness<br>Breathlessness requiring admission or supplementary oxygen | Other: Biomarker tests for participant profiling<br>* Combination of digital and physical tests to objectify measures relevant for breathlessness<br>|
| Moderate Breathlessness<br>Breathlessness requiring medical intervention < 24 hours without meeting the criteria for severe breathlessness | Other: Biomarker tests for participant profiling<br>* Combination of digital and physical tests to objectify measures relevant for breathlessness<br>|
| Mild Breathlessness<br>Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan | Other: Biomarker tests for participant profiling<br>* Combination of digital and physical tests to objectify measures relevant for breathlessness<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician assessed severity of breathlessness | Breathlessness requiring admission or supplementary oxygen, breathlessness requiring intervention < 24 hours, Breathlessness requiring medical intervention within 24 hours without meeting the criteria for severe breathlessness, Breathlessness not requiring any medical intervention within 24 hours other than a dose change in the individuals pre-established pharmacological treatment plan | 1 day (One-time assessment during a participant reported episode of breathlessness) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breathlessness, COPD, Asthma, Asthma Chronic, Wheezing, Dyspnea, Shortness of Breath