QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial) (QUIET)

QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease: Results of a Single-center, Randomized, Double-blind, Placebo-controlled Study (The QUIET Trial)

The goal of this randomized, double-blind, single-center clinical trial is to learn if medical devices work to decrease nocturnal symptoms of GERD gastroesophageal reflux disease in adults' patients and improve sleeping time, quality of sleep and quality of life of patients with nocturnal GERD symptoms. It will also teach us about safety, tolerability and improvement of patient's quality of life during and after taking medical device. The main questions it aims to answer are:

• Does medical device relieve reflux symptoms during night sleep?
• Does medical device improve the quality of sleep and quality of life life of patients with GERD symptoms? Researchers will compare medical device to a placebo (a look-alike substance that contains no drug) to see if medical device works in nocturnal GERD gastroesophageal reflux disease.

Participants will:

• Take medical device or a placebo every day just before sleeping (1 times a day) for 14 days
• Visit the clinic 2 times during 14 days of this study for checkups and tests
• Keep a diary of their symptoms and the number of times they use a medical device
• Fill out the form to collect all necessary data. Medical device or placebo will be prepared in same looking sachets of 10 ml liquid. Medical device or placebo will be administered orally, at a dose of 10 ml one time daily just before bedtime for 14 days. The liquid should be drunk slowly, in small sips direct from the sachets.

Study Overview

• Status: Recruiting
• Conditions: Non-Erosive Gastro-Esophageal Reflux Disease; GERD (Gastroesophageal Reflux Disease); Nocturnal Symptoms of GERD; Sleep Disorders in GERD
• Intervention / Treatment: Device: Medical Device vs Placebo

Detailed Description

This medical device was developed as a modern therapeutic alternative, offering rapid symptom relief and long-term protective effects on the esophageal mucosa. The introduction of medical device aims to expand the available therapeutic options for patients suffering from nocturnal GERD symptoms and to support physicians in selecting optimal therapy. Thanks to its innovative formula, medical device can avoid the rising the symptoms, provide improved well-being , improved lenght and quality of sleep , quality of life and reduce the frequency of acute medication use.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Zaorska, MD; Phone Number: +48602229443; Email: zaorska.ania@gmail.com

Study Locations

• Poland
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 04-501
      • Not yet recruiting
      • Medical Network Sp z o.o.
      • Contact: Tomasz Połeć; Phone Number: +48608337103; Email: tomasz.polec@cellmedis.com
      • Sub-Investigator: Konrad Lewandowski, MD, PhD
    • Warsaw, Masovian Voivodeship, Poland, 04-501
      • Recruiting
      • Medical Network Sp z o.o.
      • Contact: Tomasz Polec; Phone Number: +48608337103; Email: tomasz.polec@cellmedis.com
      • Principal Investigator: Grażyna Prof Rydzewska-Wyszkowska, Prof MD PhD
      • Sub-Investigator: Konrd MD PhD Lewandowski, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of gastroesophageal reflux disease based on the presence of typical symptoms of heartburn and/or regurgitation at least 6 months before the screening visit, confirmed by the investigator.
2. Erosive reflux disease (ERD), Barrett's esophagus, and other esophageal abnormalities confirmed by gastroscopy within the last 6 months by the investigator based on medical records.

3. Use of proton pump inhibitors in a single morning dose for at least two months prior to study entry, with an inadequate response to these medications for nocturnal symptoms of gastrointestinal reflux, and with at least moderate sleep quality disturbances, as defined by the PSQI (Pittsburgh Sleep Quality Index) score of 5-10 points - moderate sleep disturbances. 4. Not using the following medications within the month prior to the screening visit: H2 blockers, prokinetics (itopride, prucalopride), GLP1/GIP analogues, antibiotics, baclofen, tricyclic antidepressants, serotonin and/or norepinephrine reuptake inhibitors, and/or the following medications within the week prior to the screening visit: sucralfate, antacids, and esophageal protective agents. 5. Severity of gastroesophageal reflux symptoms that reduce the patient's quality of life, as subjectively confirmed by the patient. 6. Age ≥18 years of life at the time of the screening visit. 7. At the screening visit, women of childbearing potential must not be pregnant (confirmed by a urine pregnancy test) and must not be breastfeeding, or must be of non-reproductive potential (surgically sterilized, physiologically incapable of conceiving, or at least one year postmenopausal, i.e., amenorrheic for 12 consecutive months). 8. Women of childbearing potential who have a male partner of fertile potential must use a highly effective method of contraception from the screening visit until 18 weeks after the last dose of the investigational drug. 9. Men who have sex with women of childbearing potential must agree to use barrier contraceptive methods (condoms) or abstain from sexual intercourse throughout the study, beginning at the screening visit and for at least 7 days after the last dose of the investigational medical device. 10. Ability to participate in all aspects of this clinical trial. 11. A male or female patient who is able to voluntarily give informed consent.

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   Exclusion Criteria:

1. Women who have started lactation or have a positive urine test confirming pregnancy during the study enrollment visit.2. Introduction of significant changes in diet and lifestyle during the study.3. Presence of warning signs during the study enrollment visit: dysphagia or odynophagia, unintentional weight loss of more than 5% of initial weight, symptoms of gastrointestinal bleeding, anemia, upper abdominal tumor, and persistent vomiting for 7-10 days.4. Planned use during the study: antibiotics, pro-/pre-/synbiotics, short-chain fatty acids, proton pump inhibitors, H2 blockers, prokinetics (itopride, prucalopride), GLP1/GIP analogues, antibiotics, baclofen, tricyclic antidepressants, serotonin and/or norepinephrine reuptake inhibitors, and one week before the start of the study: sucralfate, antacids, and preparations protecting the esophageal mucosa.5. Diagnosis of a serious illness (e.g., cancer). 6. : Planned hospitalization for any reason or diagnosis of any serious concomitant disease which, in the opinion of the investigator, is a contraindication to participation in the study or may compromise the safety of the patient. Translated with DeepL.com (free version) 7. Current or recent (within one year prior to randomization) history of alcohol dependence or psychoactive substance abuse.8. Active psychiatric problems that, in the investigator's opinion, may interfere with compliance with study procedures.9. Presence of unstable or uncontrolled cardiovascular disorders, moderate or severe heart failure (NYHA class III or IV), any pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematopoietic, coagulation, immunological, endocrine/metabolic disorders, or other medical disorders that, in the opinion of the investigator, could affect the results of the study or compromise the safety of the patient.10. Any person who:a. Is an employee of the study site, investigator, study organization, or Sponsor.b. Is a first-degree relative of an employee of the study site, investigator, CRO, or Sponsor.c. Is unable to attend all study visits or comply with study procedures.Translated with DeepL.com (free version)

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical device arm; Device: Esophageal barrier medical device vs placebo Esophageal barrier medical device designed to form a bioadhesive protective barrier over gastric contents and the esophageal mucosa. The mechanism of action is local and physical, reducing exposure of the esophagus to refluxate without systemic absorption. The product is administered orally according to the study protocol and evaluated in a randomized, double blind, placebo controlled design, distinguishing it from pharmacological acid suppressive therapies. Other Name: medical device	Device: Medical Device vs Placebo; Device: Medical Device vs Placebo Esophageal barrier medical device designed to form a bioadhesive protective barrier over gastric contents and the esophageal mucosa. The mechanism of action is local and physical, reducing exposure of the esophagus to refluxate without systemic absorption. The product is administered orally according to the study protocol and evaluated in a randomized, double blind, placebo controlled crossover design, distinguishing it from pharmacological acid suppressive therapies. Intervention Placebo oral formulation Other Names: Placebo,Matching placebo,Inactive comparator formulation Description: Oral placebo formulation designed to match the investigational product in appearance, taste, and administration schedule, without containing active components. It does not form a protective barrier and has no therapeutic effect. The placebo is administered according to the same protocol as the active intervention within a randomized, double blind,
Experimental: Placebo Arm; Oral placebo formulation designed to match the investigational product in appearance, taste, and administration schedule, without containing active components. It does not form a protective barrier and has no therapeutic effect. The placebo is administered according to the same protocol as the active intervention within a randomized, double blind, placebo controlled crossover design to ensure blinding and allow comparative assessment.	Device: Medical Device vs Placebo; Device: Medical Device vs Placebo Esophageal barrier medical device designed to form a bioadhesive protective barrier over gastric contents and the esophageal mucosa. The mechanism of action is local and physical, reducing exposure of the esophagus to refluxate without systemic absorption. The product is administered orally according to the study protocol and evaluated in a randomized, double blind, placebo controlled crossover design, distinguishing it from pharmacological acid suppressive therapies. Intervention Placebo oral formulation Other Names: Placebo,Matching placebo,Inactive comparator formulation Description: Oral placebo formulation designed to match the investigational product in appearance, taste, and administration schedule, without containing active components. It does not form a protective barrier and has no therapeutic effect. The placebo is administered according to the same protocol as the active intervention within a randomized, double blind,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Effectiveness in terms of the percentage of achieving good quality sleep.	1. Good sleep quality, defined as achieving a PSQI (Pittsburgh Sleep Quality Index) score of 0-4 points after therapy.	from enrollment to the end of treatment at 14 days
2. Effectiveness in terms of the percentage of improvement in sleep quality.	2. Improvement in sleep quality, defined as a decrease in the total PSQI (Pittsburgh Sleep Quality Index) score by ≥ 3 points at the end of therapy compared to the baseline value	from enrollment to the end of treatment at 14 days
3. Effectiveness in term of in terms of the percentage of no complaints during sleep and QoL.	3. No sleep complaints, defined as a score of 0 on the question "How does heartburn interfere with your sleep?" in the GERD-HRQL (Gastroesophageal Reflux Disease Health-Related Quality of Life Questionnaire) after therapy.	from enrollment to the end of treatment at 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in quality of life	1. Improvement in quality of life, defined as a decrease of ≥ 5 points in the total score of the 36-Item Short Form Survey (SF-36) at the end of therapy compared to the baseline value.	from enrollment to the end of treatment at 14 days

Collaborators and Investigators

• Sponsor: Cellmedis
• Collaborators: Medical Network Sp. z o.o.
• Investigators: Principal Investigator: Grażyna Rydzewska-Wyszkowska, Prof MD PhD, National Medical Institute of the Ministry of the interior and Adminstration PIM MSWiA

Study record dates

Study Major Dates

• Study Start (Estimated): July 9, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: NERD; Sleep disturbances in reflux disease; Sleep disorders in GERD; Quality of sleep in GERD
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: AZ002-01-01 (QUIET); CIV-PL-26- 03-057035 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available due to privacy considerations and applicable data protection regulations. Aggregated and anonymized results will be reported in scientific publications. Data may be available from the corresponding author upon reasonable request, subject to institutional approval and data sharing agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No