Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

May 9, 2022 updated by: Sanome
The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants having experienced episode of breathlessness during the past 12 months triggering interaction with a health care professional.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe Breathlessness
Breathlessness requiring admission or supplementary oxygen
Other: Biomarker tests for participant profiling
Combination of digital and physical tests to objectify measures relevant for breathlessness
Moderate Breathlessness
Breathlessness requiring medical intervention < 24 hours without meeting the criteria for severe breathlessness
Other: Biomarker tests for participant profiling
Combination of digital and physical tests to objectify measures relevant for breathlessness
Mild Breathlessness
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
Combination of digital and physical tests to objectify measures relevant for breathlessness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician assessed severity of breathlessness
Time Frame: 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
1 day (One-time assessment during a participant reported episode of breathlessness)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sentinel - 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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