Sleep-related breathing disorders
Conditions
Interventions
Trade Name: Pantozol 40 mg
Product Name: Pantozol 40mg tablets
Product Code: BY1023
Pharmaceutical Form: Tablet
INN or Proposed INN: Pantoprazole
CAS Number: 102625-70-7
Current Sponsor code: BY1023
O
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this proof-of-concept study is to assess the potential benefit of pantoprazole for patients with and without evidence of GERD and sleep-related breathing disorders;Secondary Objective: ;Primary end point(s): Variable of primary interest: The primary variable of this study is the comparison of the ratio of snoring time over sleeping time (Snoring Index) Secondary variables: - Change in ventilation (oral / nasal flow) including: - Peakflow Vmax - Tidal volume (Vt) - Change in Apnea-Hypopnea index - Comparison of the ratio of respiratory cycles with and without snoring - Changes in Polysomnography: - EEG - EOG - EMG - ECG - Blood Gas Analysis - Proportion of REM phases - Proportion of NREM stage 3 and 4 - Arousal Index (according to ASDA criteria) - Calgary Sleep Apnea Quality of Life Index - Stanford Sleepiness Scale (SSS) - Epworth Sleepiness Scale (ESS) - ReQuest - Vital signs and physical examination | — |
Countries
Germany
Outcome results
None listed