Effect of pantoprazole on sleep-related breathing disorders - EPOS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Written informed consent by the patient for study participation, prior to protocol specific procedures
- Male and female outpatients of at least 18 years of age
- Patients suffering from sleep-related breathing disorders / Upper airway resistance syndrome for at least 3 months prior to start of the study who are seeking help for their snoring
- Stratum I: Patients with evidence of GERD, Stratum II: Patients without evidence of GERD

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Signs indicating gastrointestinal diseases and/or other causes of sleep disturbances as specified:
- Primary insomnia (according to DSM-IV)
- Patients under nCPAP/BiPAP during the last week
- Zollinger-Ellison syndrome or other gastric hypersecretory condition
- Previous acid-lowering surgery or other surgery of the oesophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)
- Known presence of obstructive esophageal strictures, Schatzki’s ring, esophageal diverticula, esophageal varices, achalasia or Barrett‘s esophagus with known high-grade dysplasia or longer than 3 cm

Other concomitant diseases:
- Acute respiratory tract infection
- Severe or unstable cardiovascular (e.g., severe angina pectoris, post myocardial infarction and ventricular extra systoles), pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; haematological disorder; any other clinically significant medical condition that could increase the risk to the study participant
- Malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer
- Hypersensitivity to one of the compounds of the study medication
- Alcohol, drug or medication abuse within the past year
- Severe psychiatric or neurological disorders

Special restrictions for female patients:
- Pregnant or nursing female patients
- Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized / hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases

Previous medication:
- PPIs and H2-receptor antagonists during the last 2 weeks before intake of study medication
- Any medication for the purpose of the eradication of H. pylori during the last 3 months before intake of study medication

Concomitant medication
- PPIs (except study medication), H2-receptor antagonists
- Ketoconazole or other drugs with pH-dependent absorption
- PPIs in combination with antibiotics for the purpose of the eradication of H. pylori
- Onset of daily psychotropic medication
- Regular intake or onset of hypnotics, e.g. benzodiazepines, chloralhydrate and combinations, barbiturates (exception: mild phytotherapeutics (e.g. valerian, hop and combinations))

Others:
- Patients who are expected to be non-compliant and/or not cooperative
- Participation in a clinical study within the last 30 days prior to the start of the study
- Patients who have participated already in this study
- Patients who are employees at the investigational site, relatives or spouse of the investigator
- Any donation of germ cells, blood, organs, or bone marrow during the course of the study
- Patients who are not contractually capable