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

Summary

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.

Conditions

• Nocturnal Symptoms of GERD
• Sleep Disorders in GERD
• GERD (Gastroesophageal Reflux Disease)
• Non-Erosive Gastro-Esophageal Reflux Disease

Interventions

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,

Sponsors & Collaborators

• Medical Network Sp. z o.o.

  collaborator UNKNOWN

• Cellmedis

  lead INDUSTRY

Principal Investigators

• Grażyna Rydzewska-Wyszkowska, Prof MD PhD · National Medical Institute of the Ministry of the interior and Adminstration PIM MSWiA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-09

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• Poland

Study Locations