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.
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
- Conditions the study is for
- GERD Gastroesophageal Reflux Disease, Laryngopharyngeal Reflux Disease
- 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.
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Inselspital Bern
Bern, 3010
Nina Moser, Dr. med., 0316323723 ext. 0041, nina.moser@insel.ch
Yves Borbély, Dr. med.
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:
- Do patients with confirmed reflux have a typical pattern of changes in their voice?
- Can these changes be reliably determined via voice analyses?
- 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:
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| GERD-Group | Patients with confirmed gastroesophageal reflux in diagnostics Receives: Diagnostic Test: Voice sample; Recording with microphone + Questionnaire | |
| Non-GERD-Group | Patients 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.
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)
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
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.
- First posted11 Jul 2024
- Study start10 Apr 2024
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Borbély, Dr. med., Principal investigator, Insel Gruppe AG, University Hospital Bern
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Voice of Reflux: Typical Vocal Biomarkers in Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT06495606
- Acronym / sponsor ID
- 2023-02361
- Keywords
- GERD, LPRD, Reflux, Voice, Vocal Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Do patients with confirmed reflux have a typical pattern of changes in their voice?
- Can these changes be reliably determined via voice analyses?
- 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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GERD-Group | – | Diagnostic Test: Voice sample; Recording with microphone + QuestionnairePatients with confirmed gastroesophageal reflux in diagnostics |
| Non-GERD-Group | – | Diagnostic Test: Voice sample; Recording with microphone + QuestionnairePatients with confirmed absence of gastroesophageal reflux in diagnostics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (4 listed)
- Age above 18
- Informed consent
- Undergoing gastroesophageal reflux diagnostic according to the current standard
- Basic reading skills in German or English
Key exclusion criteria (4 listed)
- Age below 18
- No basic reading skills in German or English
- Diseases with altered voice
- Laryngopharyngeal surgery or interventions in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice sample; Recording with microphone + QuestionnaireVoice 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 | Diagnostic test | GERD-Group, Non-GERD-Group |
Primary outcome
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
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.
2 secondary outcomes
To identify if there is a consistent correlation between vocal biomarkers and described symptoms of reflux
Time frame: Comparrison vocal biomarkers in voice recordings and results of questionnaire at enrollment and in GERD-Group additionally 5 months after start treatment
To identify if there is a consistent correlation between vocal biomarkers and described vocal symptoms
Time frame: Comparisson of vocal biomarkers in voice recording and symptoms in questionnaire at enrollement and additionally in GERD-Group 5 months after start treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Borbély, Dr. med. principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
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.