Obesity Hypoventilation Syndrome Clinical Trial
Official title:
Multimodal Measurement of Respiratory Muscle Strength by Using Volitional and Non-volitional Tests in Patients With Obesity Hypoventilation Syndrome (OHS), Obesity-associated Hypoventilation and OHS-Risk-Patients to Evaluate Pathophysiological Determinants and Predictors for the Presence of a Sleep-related Hypoventilation Requiring Treatment in Obese Patients
NCT number | NCT03854058 |
Other study ID # | WI_18-340 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | December 2024 |
Using an extensive set of both volitional and non-volitional tests of respiratory muscle function and strength it is the aim of this study to - identify potential determinants for the development of obesity hypoventilation - to identify predictors for the presence of a sleep-related hypoventilation requiring treatment in obese patients
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - patients with BMI > 30 and obesity-associated hypoventilation stages I - IV - patients with BMI > 30 and elevated OHS-risk (= obstructive sleep apnea without hypercapnia) - age:18-80 years - capacity to consent Exclusion Criteria: - any other disease, that causes ventilatory insufficiency - pacemaker, defibrillators or device for deep brain or vagus nerve stimulation - esophagitis, Barrett-esophagus, esophageal cancer - acute gastritis and ulcera ventriculi - epilepsy - any medical, psychological or other condition impairing the patient's ability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Germany | Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V. | Solingen | Nordrhein-Westfalen |
Lead Sponsor | Collaborator |
---|---|
Wissenschaftliches Institut Bethanien e.V |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Carbon dioxide rebreathing test | minute volumen (L/min) | 1 day | |
Primary | transdiaphragmatic pressure (non-volitional) | difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves | 1 day | |
Primary | peripheral nervous system (non-volitional) | electroneurography after posterior magnetic stimulation of the phrenic nerves | 1 day | |
Primary | diaphragmal ultrasound - excursion (non-volitional) | excursion of the diaphragm | 1 day | |
Primary | diaphragmal ultrasound - thickness (non-volitional) | thickness of the diaphragm | 1 day | |
Primary | P0.1 (volitional) | mouth occlusion pressure (kPa) | 1 day | |
Primary | PImax (volitional) | maximal inspiratory mouth pressure (kPa) | 1 day | |
Secondary | Comparison of PImax and transdiaphragmatic pressure | Correlation between PImax and transdiaphragmatic pressure | 1 day |
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