Digital Voice Analysis as a Measure of Frailty and Distress (DIVAN)

January 16, 2025 updated by: University Hospital, Basel, Switzerland

Digital Voice Analysis as a Measure of Frailty and Distress. A Feasibility Study (DIVAN)

This study evaluates if it is possible to identify quantitative parameters from audio signals to describe the changes in patient's state in relation to frailty and distress.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Frailty is a common clinical syndrome especially in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality. The early detection of frailty is of importance in many patient populations to predict treatment outcomes, identify patient needs and coordinate efficient and meaningful care. An electronic assessment of the degree of distress in patients, who are unable to report, would be important to be able to routinely and objectively identify suffering in these patients. Digital voice analysis (DVA) gathers speech samples from individuals via different kinds of recording devices (smartphone, tablet, etc.) and examines a large variety of specific acoustic parameters such as for example frequency and voice quality features. This study is to analyse the potential to evaluate distress and frailty through digital voice analysis. On the contrary to the existing studies, it is intended to record audio and clinical evaluation data from the same subject multiple times during several weeks to be able to analyse temporal changes. This will allow to not only perform inter-subject but as well intra-subject comparisons of changes in audio features with changes of the patient's wellbeing over time. To make the patient speak as freely and relaxed as possible, the patient will describe different images. Different features will be extracted from the audios and potential candidates for a larger patient study will be identified, if data quantity permits using machine learning algorithms. Therefore this study evaluates if it is feasible to gather digital voice samples for voice analyses from cancer patients alongside conventional assessments for frailty (G8 questionnaire and distress (Distress Thermometer) to conduct first, preliminary analyses for identification of potential correlates between voice features and frailty or distress and between changes over time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4002
        • Recruiting
        • Palliativzentrum Hildegard, Basel
        • Contact:
        • Principal Investigator:
          • Jan Gärtner, Prof. Dr. med.
      • Liestal, Switzerland, 4410
        • Recruiting
        • Kantonsspital Baselland, Klinik für Onkologie, Hämatologie und Immuntherapie
        • Contact:
        • Principal Investigator:
          • Marcus Vetter, PD Dr. med.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient recruitment will be performed at the different participating clinical sites by the investigator

Description

Inclusion Criteria:

  • Active cancer or haemato-oncological malignancy
  • Adults (≥ 18 years)
  • Ability to understand, speak and read German language fluently
  • Ability to provide written consent
  • Sufficient or corrected vision to see the images
  • Sufficient auditory comprehension for participation in the study based on the therapist's clinical opinion
  • Ability to concentrate for 20-30 minutes based on the investigator's clinical opinion
  • Signed informed consent to the study

Exclusion Criteria:

  • Aphonia, dysphonia or other obvious voice alterations of patient's voice
  • Life-expectancy shorter ≤ 14 days as judged by a physician or nurse via "surprise question"
  • Breathlessness whilst speaking
  • Cognitive impairment as judged by physician or Mini-Cog in the G8 screening tool
  • Severe physical, emotional or existential suffering because of which the enrollment and participation in the study would result in patient burden, as judged by the treating physicians and their multiprofessional team members

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort A: palliative care center
Patients from a palliative care center (Palliativzentrum Hildegard, Basel)
Other: Data acquisition: Speech acquisition
Speech test with synchronized audio and video recording. The speaking exercises and the audio and video recording will be done using a tablet computer and an application developed in-house. Freely available images showing different scenes will be integrated and displayed on the tablet to be described by the patient. The goal is to have at least two and maximum four of them described with several sentences by each patient per session. Parameters will be extracted from the patient's audio data to estimate the changes in distress and frailty.
Diagnostic test: Data acquisition: G8 Screening tool
The G8 screening tool consists of seven items dealing with food intake, weight loss, mobility, neuropsychological problem, body mass index, prescription drug, and self-perception of health, from the Mini-Nutritional Assessment (MNA) questionnaire and was developed specifically for elderly cancer patients. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.
Diagnostic test: Data acquisition: Distress Thermometer
The distress thermometer (DT) is a measure of psychological distress in cancer patients. The instrument is a self-reported tool using a 0-to-10 rating scale.
Cohort B: mid-size cancer center
Patients from a mid-size cancer center (Tumorzentrum Baselland)
Other: Data acquisition: Speech acquisition
Speech test with synchronized audio and video recording. The speaking exercises and the audio and video recording will be done using a tablet computer and an application developed in-house. Freely available images showing different scenes will be integrated and displayed on the tablet to be described by the patient. The goal is to have at least two and maximum four of them described with several sentences by each patient per session. Parameters will be extracted from the patient's audio data to estimate the changes in distress and frailty.
Diagnostic test: Data acquisition: G8 Screening tool
The G8 screening tool consists of seven items dealing with food intake, weight loss, mobility, neuropsychological problem, body mass index, prescription drug, and self-perception of health, from the Mini-Nutritional Assessment (MNA) questionnaire and was developed specifically for elderly cancer patients. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.
Diagnostic test: Data acquisition: Distress Thermometer
The distress thermometer (DT) is a measure of psychological distress in cancer patients. The instrument is a self-reported tool using a 0-to-10 rating scale.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of mean fundamental frequency extracted from the patient's audio data
Time Frame: during a 16-week period for each patient
Change of mean fundamental frequency extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of first few formants (F1, F2)
Time Frame: during a 16-week period for each patient
Change of first few formants (F1, F2) extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of jitter (variation in F0 from cycle to cycle)
Time Frame: during a 16-week period for each patient
Change of jitter (variation in F0 from cycle to cycle) extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of shimmer (variation in peak-to-peak amplitude)
Time Frame: during a 16-week period for each patient
Change of shimmer (variation in peak-to-peak amplitude) extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of skewness
Time Frame: during a 16-week period for each patient
Change of skewness extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of kurtosis
Time Frame: during a 16-week period for each patient
Change of kurtosis extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of voice strength (volume) of the vowel
Time Frame: during a 16-week period for each patient
Change of voice strength (volume) of the vowel extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of duration of length of the answer
Time Frame: during a 16-week period for each patient
Change of duration of length of the answer extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of verbal fluency
Time Frame: during a 16-week period for each patient
Change of verbal fluency extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of word duration of individual words
Time Frame: during a 16-week period for each patient
Change of word duration of individual words extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient
Change of duration of the breaks between the words
Time Frame: during a 16-week period for each patient
Change of duration of the breaks between the words extracted from the patient's audio data to estimate the changes in distress and frailty.
during a 16-week period for each patient

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcus Vetter, PD Dr. med., Kantonsspital Baselland, Klinik für Onkologie, Hämatologie und Immuntherapie

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-01461; th23Vetter

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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