Nocturnal Symptoms of GERDQUIETNCT07700342
QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial)
A study of Nocturnal Symptoms of GERD and Sleep Disorders in GERD, run by Cellmedis at 2 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nocturnal Symptoms of GERD, Sleep Disorders in GERD, GERD (Gastroesophageal Reflux Disease)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesPoland
- Study dates
- 9 Jul 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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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Who cannot join
- 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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Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Not yet recruiting
Medical Network Sp z o.o.
Warsaw, Masovian Voivodeship, 04-501
Tomasz Połeć, +48608337103, tomasz.polec@cellmedis.com
Konrad Lewandowski, MD, PhD
- Recruiting
Medical Network Sp z o.o.
Warsaw, Masovian Voivodeship, 04-501
Tomasz Polec, +48608337103, tomasz.polec@cellmedis.com
Grażyna Prof Rydzewska-Wyszkowska, Prof MD PhD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Nocturnal Symptoms of GERD, Sleep Disorders in GERD, GERD (Gastroesophageal Reflux Disease), Non-Erosive Gastro-Esophageal Reflux Disease
- Being tested
- Medical Device vs Placebo
- Keywords
- Sleep disturbances in reflux disease, Sleep disorders in GERD, Quality of sleep in GERD, NERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device vs PlaceboDevice
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,
| Study group | Role | What they receive |
|---|---|---|
| Medical device arm | Experimental | 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 Receives: Device: Medical Device vs Placebo |
| Placebo Arm | Experimental | 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. Receives: Device: Medical Device vs Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Effectiveness in terms of the percentage of achieving good quality sleep.
- Good sleep quality, defined as achieving a PSQI (Pittsburgh Sleep Quality Index) score of 0-4 points after therapy.
Measured: from enrollment to the end of treatment at 14 days
2. Effectiveness in terms of the percentage of improvement in sleep quality.
- 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
Measured: 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.
- 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.
Measured: from enrollment to the end of treatment at 14 days
Secondary outcomes (1)
Improvement in quality of life
- 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.
Measured: from enrollment to the end of treatment at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start9 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal Symptoms of GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, prospective, randomized, placebo-controlled, double-blind, study to evaluate the efficacy and safety of the GerdOXX Plus Noc medical device compared to placebo. 50 patients with a confirmed diagnosis of non-erosive gastroesophageal reflux disease, presenting with nocturnal symptoms despite the use of proton pump inhibitors in a single morning dose will be randomly assigned in a 1:1 ratio, 25 in each group, to receive GerdOXX Plus Noc or Placebo during 14 days. After randomization in a 1:1 ratio, oral administration of GerdOXX Plus Noc or placebo at a dose of 10 mL sirup once daily, every evening just before bedtime for 14 days. Duration of the study lasts 14 days. GerdOXX Plus Noc or placebo will be administered orally, in a dose of 10 ml one time a day evening just before bedtime 10 ml for 14 days. The medicle device should be drunk slowly, in small sips.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellmedis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Network Sp. z o.o.
- Responsible party
- Sponsor
- Investigators
- Grażyna Rydzewska-Wyszkowska, Prof MD PhD, Principal investigator, National Medical Institute of the Ministry of the interior and Adminstration PIM MSWiA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700342
- Sponsor's protocol ID
- AZ002-01-01 (QUIET)
- Other IDs
- CIV-PL-26- 03-057035
- Acronym
- QUIET
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07700342
- Acronym / sponsor ID
- QUIET / AZ002-01-01 (QUIET)
- Conditions
- Nocturnal Symptoms of GERD, Sleep Disorders in GERD, GERD (Gastroesophageal Reflux Disease), Non-Erosive Gastro-Esophageal Reflux Disease
- Keywords
- Sleep disturbances in reflux disease, Sleep disorders in GERD, Quality of sleep in GERD, NERD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CellmedisIndustry (pharma, biotech, devices)
- Collaborators
- Medical Network Sp. z o.o.
- Study start
- 9 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, prospective, randomized, placebo-controlled, double-blind, study to evaluate the efficacy and safety of the GerdOXX Plus Noc medical device compared to placebo. 50 patients with a confirmed diagnosis of non-erosive gastroesophageal reflux disease, presenting with nocturnal symptoms despite the use of proton pump inhibitors in a single morning dose will be randomly assigned in a 1:1 ratio, 25 in each group, to receive GerdOXX Plus Noc or Placebo during 14 days. After randomization in a 1:1 ratio, oral administration of GerdOXX Plus Noc or placebo at a dose of 10 mL sirup once daily, every evening just before bedtime for 14 days. Duration of the study lasts 14 days. GerdOXX Plus Noc or placebo will be administered orally, in a dose of 10 ml one time a day evening just before bedtime 10 ml for 14 days. The medicle device should be drunk slowly, in small sips.
| Arm | Type | Receives |
|---|---|---|
| Medical device arm | Experimental | Device: Medical Device vs PlaceboDevice: 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 |
| Placebo Arm | Experimental | Device: Medical Device vs PlaceboOral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 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.
- 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.
- -
Key exclusion criteria (2 listed)
- 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)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device vs PlaceboDevice: 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, | Device | Medical device arm, Placebo Arm |
Primary outcome
1. Effectiveness in terms of the percentage of achieving good quality sleep.
Time frame: from enrollment to the end of treatment at 14 days
1. Good sleep quality, defined as achieving a PSQI (Pittsburgh Sleep Quality Index) score of 0-4 points after therapy.
2. Effectiveness in terms of the percentage of improvement in sleep quality.
Time frame: from enrollment to the end of treatment at 14 days
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
3. Effectiveness in term of in terms of the percentage of no complaints during sleep and QoL.
Time frame: from enrollment to the end of treatment at 14 days
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.
1 secondary outcome
Improvement in quality of life
Time frame: from enrollment to the end of treatment at 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grażyna Rydzewska-Wyszkowska, Prof MD PhD principal investigator
National Medical Institute of the Ministry of the interior and Adminstration PIM MSWiA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Nocturnal Symptoms of GERD and Sleep Disorders in GERD, run by Cellmedis at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Zaorska, MD (+48602229443, zaorska.ania@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Effectiveness in terms of the percentage of achieving good quality sleep. (time frame: from enrollment to the end of treatment at 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.