Actively Recruiting

Age: 18Years +
All Genders
ID06495606

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-07-11

94

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Gastroesophageal reflux disease (GERD) occurs when stomach acid flows back into the esophagus and throat, causing symptoms like heartburn, acid regurgitation, throat irritation, hoarseness, difficulty swallowing, and a dry cough. This condition may be caused by weak lower esophageal sphincter muscles, hiatal hernia, or movement disorders in the esophagus or stomach. Researchers are exploring whether voice samples can detect characteristic changes related to reflux, potentially offering a simple, non-invasive way to identify this condition early. This observational study involves patients undergoing standard diagnostic tests for reflux, including gastroscopy, esophageal manometry, and 24-hour impedance pH measurement. Participants will be grouped into those with confirmed reflux and those without. Voice recordings and questionnaires will be collected at diagnosis and, for reflux patients, again five months after starting treatment. The recordings will be digitally analyzed for typical vocal changes associated with reflux by a Swiss technology center. Participants will provide voice samples via microphone and complete questionnaires without needing extra hospital visits. The study lasts up to five months and stores data securely in encrypted form following strict privacy rules. Researchers aim to identify vocal markers linked to reflux and understand how they relate to symptoms and treatment effects, with results expected in 2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age above 18
  • Provided informed consent
  • Undergoing gastroesophageal reflux diagnostic according to the current standard
  • Basic reading skills in German or English
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At enrollment and for GERD participants, an additional assessment 5 months after start of treatment

Participants undergo voice sample recordings and complete questionnaires to identify vocal biomarkers related to gastroesophageal reflux disease (GERD).

1 visit at enrollment and 1 follow-up visit for GERD participants

Long-term Monitoring

Duration - Approximately 5 months after treatment start

Participants in the GERD group have voice samples recorded again 5 months after starting treatment to monitor changes in vocal biomarkers.

1 follow-up visit (in-person) for GERD participants

Trial Site Locations

Total: 1 location

1

Universitätsspital Inselspital Bern

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

N

Nina Moser, Dr. med.

Y

Yves Borbély, Dr. med.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Frequently Asked Questions

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