QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (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.

This description comes directly from the study's public registry record.

Anna Zaorska, MD  ·  +48602229443  ·  zaorska.ania@gmail.com

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