Trends in voice characteristics in patients with heart failure (VENTURE) in Switzerland: Protocol for a longitudinal observational pilot study

Abstract

Introduction Heart Failure (HF) is a major health and economic issue worldwide. HF-related expenses are largely driven by hospital admissions and re-admissions, many of which are potentially preventable. Current self-management programs, however, have failed to reduce hospital admissions. This may be explained by their low predictive power for decompensation and high adherence requirements. Slight alterations in the voice profile may allow to detect decompensation in HF patients at an earlier stage and reduce hospitalizations. This pilot study investigates the potential of voice as a digital biomarker to predict health status deterioration in HF patients. Methods and analysis In a two-month longitudinal observational study, we collect voice samples and HF-related quality-of-life questionnaires from 35 stable HF patients. Patients use our developed study application installed on a tablet at home during the study period. From the collected data, we use signal processing to extract voice characteristics from the audio samples and associate them with the answers to the questionnaire data. The primary outcome will be the correlation between voice characteristics and HF-related quality-of-life health status. Ethics and dissemination The study was reviewed and approved by the Cantonal Ethics Committee Zurich (BASEC ID:2022-00912). Results will be published in medical and technical peer-reviewed journals.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

Grant numbers: 22026 Initials of authors who received the award: Filipe Barata Full name of the funder: Hasler Foundation (Haslerstiftung) URLs to sponsors websites: https://haslerstiftung.ch/en/welcome-to-the-hasler-foundation/ The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Kantonale Ethikkommission Zurich (Ethics committee of Zurich) gave ethical approval for this work with BASEC Number 2022-00912.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Data cannot be shared publicly because of ethical requirements. Data are available from the Kantonale Ethikkommission (Cantonal Ethics Committee Zurich) BASEC ID:2022-00912 (contact via info.kek@kek.zh.ch) for researchers who meet the criteria for access to confidential data.

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