Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495606
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
The Voice of Reflux - Backflow of Gastric Juice Leads to Irritation of the Vocal Folds Are There Typical Differences in the Voice
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
The Voice of Reflux Typical Vocal Biomarkers in Patients With Gastroesophageal Reflux Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
If gastric juice refluxes back into the oesophagus and up into the throatpharynxmouth 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
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
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None