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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity Hypoventilation Syndrome
- Sponsor
- Wissenschaftliches Institut Bethanien e.V
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- transdiaphragmatic pressure (non-volitional)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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
- •any medical, psychological or other condition impairing the patient's ability to provide informed consent
Outcomes
Primary Outcomes
transdiaphragmatic pressure (non-volitional)
Time Frame: 1 day
difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves
diaphragmal ultrasound - thickness (non-volitional)
Time Frame: 1 day
thickness of the diaphragm
P0.1 (volitional)
Time Frame: 1 day
mouth occlusion pressure (kPa)
peripheral nervous system (non-volitional)
Time Frame: 1 day
electroneurography after posterior magnetic stimulation of the phrenic nerves
Carbon dioxide rebreathing test
Time Frame: 1 day
minute volumen (L/min)
diaphragmal ultrasound - excursion (non-volitional)
Time Frame: 1 day
excursion of the diaphragm
PImax (volitional)
Time Frame: 1 day
maximal inspiratory mouth pressure (kPa)
Secondary Outcomes
- Comparison of PImax and transdiaphragmatic pressure(1 day)