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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05304494
Other study ID # Sentinel - 001
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 2022
Est. completion date March 2024

Study information

Verified date March 2022
Source Sanome
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design


Intervention

Other:
Biomarker tests for participant profiling
Combination of digital and physical tests to objectify measures relevant for breathlessness

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanome

References & Publications (5)

Barnes N, Calverley PM, Kaplan A, Rabe KF. Chronic obstructive pulmonary disease and exacerbations: patient insights from the global Hidden Depths of COPD survey. BMC Pulm Med. 2013 Aug 23;13:54. doi: 10.1186/1471-2466-13-54. — View Citation

Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG; Standards for Reporting of Diagnostic Accuracy. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med. 2003 Jan 7;138(1):W1-12. — View Citation

Coutinho AD, Lokhandwala T, Boggs RL, Dalal AA, Landsman-Blumberg PB, Priest J, Stempel DA. Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population. Int J Chron Obstruct Pulmon Dis. 2016 Jun 8;11:1223-31. doi: 10.2147/COPD.S102570. eCollection 2016. — View Citation

Smith AK, Currow DC, Abernethy AP, Johnson MJ, Miao Y, Boscardin WJ, Ritchie CS. Prevalence and Outcomes of Breathlessness in Older Adults: A National Population Study. J Am Geriatr Soc. 2016 Oct;64(10):2035-2041. doi: 10.1111/jgs.14313. Epub 2016 Sep 7. — View Citation

Tobin MJ, Laghi F, Jubran A. Why COVID-19 Silent Hypoxemia Is Baffling to Physicians. Am J Respir Crit Care Med. 2020 Aug 1;202(3):356-360. doi: 10.1164/rccm.202006-2157CP. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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