Asthma, Asthma Chronic, Breathlessness, COPD, Dyspnea, Shortness of Breath, Wheezing
Conditions
Keywords
Breathlessness, COPD, Asthma, Asthma Chronic, Wheezing, Dyspnea, Shortness of Breath
Brief summary
The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.
Interventions
OTHERBiomarker tests for participant profiling
Combination of digital and physical tests to objectify measures relevant for breathlessness
Sponsors
Sanome
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician assessed severity of breathlessness | 1 day (One-time assessment during a participant reported episode 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 |
Outcome results
None listed