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GERD Gastroesophageal Reflux DiseaseNCT06495606

"The Voice of Reflux" - Backflow of Gastric Juice Leads to Irritation of the Vocal Folds: Are There Typical Differences in the Voice?

An observational study of GERD Gastroesophageal Reflux Disease and Laryngopharyngeal Reflux Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

If gastric juice refluxes back into the oesophagus and up into the throat/pharynx/mouth area, causing discomfort or injury, this is known as reflux disease (reflux). Classic symptoms include a burning pain in the middle of the upper abdomen, chest or throat (so-called heartburn), regurgitation of food (acid… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Voice sample; Recording with microphone + Questionnaire
How many people
94 participants
Where
1 siteSwitzerland
Study dates
10 Apr 2024to Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: We include patients undergoing GERD diagnostic with esophagogastroduodenoscopy plus biopsies, high-resolution manometry and 24-hour impedance-pH-metry, according to the todays standard in reflux diagnostics, in the Bauchzentrum of University Hospital Bern Inselspital. After this standardized examination, there will be patients with confirmed gastroesophageal reflux disease as well as patients with confirmed absence of a GERD. Out of these patients, we collect N=47 patients with confirmed gastroesophageal reflux disease (GERD-Group) and N=47 patients with confirmed absence of gastroesophageal reflux disease as a control group (Non-GERD-Group).

Who may be able to join

  • Age above 18
  • Informed consent
  • Undergoing gastroesophageal reflux diagnostic according to the current standard
  • Basic reading skills in German or English

Who cannot join

  • Age below 18
  • No basic reading skills in German or English
  • Diseases with altered voice
  • Laryngopharyngeal surgery or interventions in the past

Trial locations and contacts

1 site in 1 country.

Nina Moser, Dr. med. contact

+41316323723

nina.moser@insel.ch

Yves Borbély, Dr. med. contact

+41316323723

Yves.Borbely@insel.ch

Switzerland1 site, 1 recruiting
  • Universitätsspital Inselspital Bern

    Bern, 3010

    Nina Moser, Dr. med., 0316323723 ext. 0041, nina.moser@insel.ch

    Yves Borbély, Dr. med.

    Recruiting

Other trials in Switzerland

About this study

Official title: The Voice of Reflux: Typical Vocal Biomarkers in Patients With Gastroesophageal Reflux Disease

If gastric juice refluxes back into the oesophagus and up into the throat/pharynx/mouth area, causing discomfort or injury, this is known as reflux disease (reflux). Classic symptoms include a burning pain in the middle of the upper abdomen, chest or throat (so-called heartburn), regurgitation of food (acid regurgitation), foreign body sensation in the throat area. There are also changes in the voice, hoarseness, difficulty clearing the throat, difficulty swallowing or a dry, irritating cough due to the chemical irritation of the vocal folds by the gastric juice. There are various causes of reflux. Often there is a weakness of the lower oesophageal sphincter or a hiatal hernia, which favours the reflux of gastric juice. Sometimes there are also movement disorders in the oesophagus or stomach with insufficiently efficient transport of food and liquids.

After a consultation with a specialist, three further standard examinations are ordered as a matter of priority for a proper reflux diagnosis:

Read more
  • Gastroscopy: a tube-shaped camera can be used to view the mouth, pharynx, throat, oesophagus, stomach and the beginning of the duodenum and, if necessary, small tissue samples can be taken.
  • Oesophageal manometry: A pressure measurement of the oesophagus can detect movement disorders or a malfunction of the oesophagus and sphincter.
  • 24-hour impedance pH measurement: A small tube is placed in the oesophagus through the nose and left there for 24 hours. The probe measures how often gastric juice flows back to a certain level and how acidic this juice is.

These examinations allow reflux to be definitively diagnosed, possible causes to be identified, any further investigations to be considered and the best possible treatment to be suggested.

In these times of rapidly advancing digitalisation and increasing technical possibilities, we ask ourselves the following: If reflux changes the voice - would it be possible to detect reflux disease with voice samples the other way round? Studies are already underway in several other medical fields that are successfully analysing voice and speech samples and looking for typical changes in the voice pattern for diseases.

Our theory: Alterations typical for reflux can be found in voice samples. In future, voice samples can be used as a harmless, simple and inexpensive initial assessment for reflux.

The questions of our research project are therefore:

  1. Do patients with confirmed reflux have a typical pattern of changes in their voice?
  2. Can these changes be reliably determined via voice analyses?
  3. Could a simple voice sample become the first basic examination for reflux patients in the future?

Procedure and duration of the study:

This project will be conducted exclusively at the Inselspital Bern (monocentric = 1 hospital, national = 1 country). All persons who receive the above-mentioned standard examination for a reflux clarification are eligible for participation. The standard examination will either confirm or rule out reflux. For our research project, we want to investigate two situations:

  1. firstly, as a baseline, we would like to examine the voices of 47 participants with confirmed reflux and compare them with the voices of 47 participants with confirmed absence of reflux disease.
  2. secondly, we would like to check the voices of participants with confirmed reflux again 5 months after the start of treatment and compare them with their initial situation.

Participants will complete a questionnaire and provide a voice sample (short simple recording into a microphone). Participation in the research project does not require any additional hospital visits or consultation appointments and lasts a maximum of 5 months.

The voice samples are then digitised, analysed, evaluated and searched for typical patterns of change by us in collaboration with the CSEM Neuchâtel (Centre Suisse Électronique et de Microtechnique). CSEM is an internationally recognised Swiss technology innovation centre that will help us with the sophisticated evaluation of the voice analyses. As these are simple voice recordings into a microphone, there are no additional clarifications, interventions or risks involved in participating. Data will be stored in encrypted form in a SharePoint database in strict compliance with all data protection regulations and will only be used for the agreed research project. Results are expected in 2025.

Being tested
Voice sample; Recording with microphone + Questionnaire
Keywords
GERD, LPRD, Reflux, Voice, Vocal Biomarker
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Voice sample; Recording with microphone + QuestionnaireDiagnostic test

    Voice sample recording with microphone; afterwards digitalization and comparison between GERD and Non-GERD Group and also between GERD-Group before and after GERD treatment; searching for vocal biomarkers typical for GERD

Study groups in NCT06495606
Study groupRoleWhat they receive
GERD-GroupPatients with confirmed gastroesophageal reflux in diagnostics
Receives: Diagnostic Test: Voice sample; Recording with microphone + Questionnaire
Non-GERD-GroupPatients with confirmed absence of gastroesophageal reflux in diagnostics
Receives: Diagnostic Test: Voice sample; Recording with microphone + Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify typical vocal biomarkers in the voice sample of patients with GERD

    After digitizing the vocal samples and audio pre-processing, we will extract audio features and identify the most dominating and discriminating characteristics of the signal. The following audio features will be analyzed: 1)Acoustic measures: Variation of periodicity analyzing Jitter and Shimmer, Harmonics-to-Noise-Ratio, Fundamental frequency of voice FO, Amplitude Perturbation Quotient and Pitch Perturbation Quotient and 2) Spectral analysis using the Fast-Fourier Transformation FFT with further analysis using the Mel-Spectrogram. The analysed audio features and Mel-spectrograms will be compared between participants with GERD and participants without GERD at baseline as well as between participants with GERD before and after their treatment. We want to identify, if the pre-treatment GERD-patients show significantly more pathologic acoustic measures, Mel-spectrograms or a typical combination of abnormalities.

    Measured: First acoustic voice recording at enrollement after finishing diagnostic measurements in GERD and Non-GERD Group; in GERD Group additional second acoustic voice recording 5 months after start treatment

Secondary outcomes (2)
  1. To identify if there is a consistent correlation between vocal biomarkers and described symptoms of reflux

    Do the vocal biomarkers correlate with the reflux-related symptoms reported in the questionnaires; Analysis of "GERD HRQL"- and "RSI"-Score

    Measured: Comparrison vocal biomarkers in voice recordings and results of questionnaire at enrollment and in GERD-Group additionally 5 months after start treatment

  2. To identify if there is a consistent correlation between vocal biomarkers and described vocal symptoms

    Do the vocal biomarkers correlate with the voice-related symptoms reported in the questionnaires; Analysis of "VHI-10"- and "VRQoL"-Score

    Measured: Comparisson of vocal biomarkers in voice recording and symptoms in questionnaire at enrollement and additionally in GERD-Group 5 months after start treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2024
  2. Study start10 Apr 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06495606
Sponsor's protocol ID
2023-02361
Other IDs
2023
Status last verified
Jul 2024
First submitted
3 Jul 2024
Last updated
11 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available

Questions about this trial

What is this clinical trial studying?

An observational study of GERD Gastroesophageal Reflux Disease and Laryngopharyngeal Reflux Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nina Moser, Dr. med. (+41316323723, nina.moser@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify typical vocal biomarkers in the voice sample of patients with GERD (time frame: First acoustic voice recording at enrollement after finishing diagnostic measurements in GERD and Non-GERD Group; in GERD Group additional second acoustic voice recording 5 months after start treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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