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VoIce Changes and Heart Failure

NCT02555904 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2015-09-22

No results posted yet for this study

Summary

This is an observational, single center study to evaluate if acoustic and accelerometer-based measures of voice and speech have sufficient precision to detect a change in lung fluid status for patients with confirmed acute heart failure syndrome with pulmonary congestion. The study shall be conducted in concordance with the United States FDA regulations for a non-significant risk study. Patients admitted for acute heart failure syndrome with pulmonary congestion with an expected stay greater than 3 to 4 days, who are willing and able to sign an informed consent, and who meet all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Results of this study will evaluate the sensitivity of voice and speech measures in detecting changes in lung fluid status in a symptomatic population. Up to 12 subjects will be enrolled to comparatively evaluate the voice outcome measures in this pilot study.

Conditions

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Marc Semigran, MD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-03-31
Completion
2016-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02555904 on ClinicalTrials.gov