Pre- and Post-Therapy Evaluation of Air-Associated Symptoms in Patients With Gastro-esophageal Re… (NCT07634614) | Clinical Trial Compass
By InvitationNot Applicable
Pre- and Post-Therapy Evaluation of Air-Associated Symptoms in Patients With Gastro-esophageal Reflux Disease (GERD): Assessing the Role of Speech and Language Therapy
Switzerland100 participantsStarted 2026-04-21
Plain-language summary
Patients with gastroesophageal reflux disease (GERD) may present with concomitant gas-related symptom (GRS) such as supragastric or gastric belching, and aerophagia. Identifying these patients is crucial, as their therapeutic pathway differs substantially from that of patients with "pure" reflux disease. Proceeding directly to antireflux surgery in the presence of untreated air-associated symptoms can lead to catastrophic postoperative outcomes. These partly behavioral disorders can often be effectively managed through targeted speech therapy. Following successful therapy, patients may either experience complete resolution of their symptoms or become suitable candidates for surgical treatment of GERD. As of today, there is very scarce literature on this subject.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years and older
* Initial presentation at our reflux center with reflux symptoms, with or without concomitant air-related symptoms such as belching, bloating, or abdominal distension
* Confirmed air-related pathology based on characteristic clinical findings and/or diagnostic evidence from impedance, manometry, or videofluoroscopic swallow study (VFSS)
* Verbal informed consent as documented by the investigator
Exclusion Criteria:
* Age under 18 years
* Pregnancy
* Exclusion of GERD
* Preoperative presence of a hiatal hernia with migration of \>20% of stomach in the chest
* Revisional surgery (after other procedures for reflux or at the hiatus)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of air-associated symptoms and their impact on daily life before and after targeted speech and language therapy in patients with GERD, assessed using a specifically developed patient questionnaire.
Timeframe: From start of speech therapy until interview: - Speech therapy was started earliest in January 2023, latest around January 2026. - Interviews are taking place starting in April 2026 until all have been performed, end is anticipated in fall 2026.