An Observational Study of Medical Device, HALD (Heart and Lung Diagnostic) to Obtain Heart and Lung Sound Recordings.

March 5, 2026 updated by: SonoHL

An Observational Prospective Study to Assess the Feasibility of a Cardiorespiratory Medical Device, HALD (Heart and Lung Diagnostic) and Its Ability to Obtain Heart and Lung Sound Recordings

The goal of this observational study is to learn whether the HALD investigational device can accurately record heart, and lung sounds during a routine cardiology clinic visit.

The main question aims to answer:

Can the HALD device capture heart and lung sounds in different positions and during deep breaths, and do these recordings match the sounds assessed by the investigator during a physical exam?

Participants will have a clinical assessment performed by the investigator as per clinic standard of care. After which, the HALD device vest will be applied to the chest of the participant , and heart and lung sounds will be recorded in a series of positions. The recordings will be transferred automatically to a computer and will later be listened to and assessed for accuracy.

The information collected will be used for research purposes to help understand how the device vest may be used in the future.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is looking at how well the HALD device can record heart and lung sounds during a routine cardiology clinic visit. All participants will have a required clinic exam and ECG performed. Participants who qualify and agree to participate will put on a T-shirt and wear the HALD vest while heart and lung sounds are recorded in several positions, including lying down and sitting, with normal and deep breaths. The recorded sounds will later be compared to what the investigator heard during the exam to check for validity and accuracy. All recordings are saved securely and will be used to help researchers understand how the device could support heart and lung assessments in the future.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3T2
        • Recruiting
        • Glen Centre Specilaized Medicine Clinic

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants presenting to pre-scheduled cardiology appointment, with suspected or history of known; valvular disease, heart failure, pericarditis, coronary artery disease, and other cardiovascular disease.

Description

Inclusion Criteria:

  1. Male or Female
  2. Age ≥18 years old
  3. Documented history of valvular heart disease, heart failure, pericarditis, coronary artery disease or other conditions with abnormal clinical cardiopulmonary assessment as well as control participants without abnormal physical examinations for a total of 60 participants.
  4. Must have had an echocardiogram performed within 12 months of enrollment or have a scheduled echocardiogram appointment expected within the next 12 months.
  5. Able and willing to provide written informed consent for study participation and able to comply with the required testing

Exclusion Criteria:

  1. <18 years of age
  2. Females pregnant, or lactating mothers
  3. Participant with implantable electronic devices such as pacemakers or implantable cardioverter-defibrillator (ICD)
  4. Participant has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study evaluation

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

Cohorts and Interventions

Group / Cohort
Evidence of abnormal cardiopulmonary exam and control group without abnormal exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary objection is validity and accuracy Between HALD Vest Audio Recordings and Clinical Auscultation Findings
Time Frame: From initiation of the first vest recording position to the end of the 4-minute recording period.
The number of participants recorded heart and lung sounds from the HALD vest that match the clinical cardiologist auscultation findings as evaluated by a blinded cardiologists interpretations
From initiation of the first vest recording position to the end of the 4-minute recording period.
Feasibility of HALD Vest Use: Outcome Measure: Feasibility of applying the HALD vest in a clinical setting, including ease of donning, participant comfort, workflow integration, and successful acquisition of heart and lung audio recordings.
Time Frame: From the time of the applying the vest to the participant to the end of the 4-minute recording period.
1. Percentage of participants who rated putting on the vest (with CRC assistance) as easy on a 5-point Likert scale (0 = very easy to 4 = very difficult).
From the time of the applying the vest to the participant to the end of the 4-minute recording period.
To assess participant overall physical comfort while wearing the vest in the varying recording positions.
Time Frame: From initiation of the first vest recording position to the end of the 4-minute recording period.
Percentage of participants rating comfort while wearing the vest on a 5-point Likert scale (1 = very comfortable to 5 = very uncomfortable).
From initiation of the first vest recording position to the end of the 4-minute recording period.
Measure the degree of difficulty for the research team to perform tasks required of the HALD vest device ( fitting the vest on the participant, positioning for recordings, obtaining recordings and data entry in computer )
Time Frame: From the time of the applying the vest to the participant to the end of the 4-minute recording period.
Percentage of CRCs rating the overall HALD vest workflow (fitting the vest, positioning the participant, obtaining recordings, and entering data into the SonoHL system) on a 5-point Likert scale from very easy to very difficult.
From the time of the applying the vest to the participant to the end of the 4-minute recording period.

Collaborators and Investigators

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

Sponsor

SonoHL

Investigators

  • Principal Investigator: Liskowski, MD, Cardiologist, Glen Centre Specilaized Medicine Clinic

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 (Actual)

January 7, 2026

Primary Completion (Estimated)

February 12, 2027

Study Completion (Estimated)

April 16, 2027

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HALD-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan as of yet, to be defined

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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