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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date December 2023
Source Wissenschaftliches Institut Bethanien e.V
Contact Anja Pietzke-Calcagnile, Dr.
Phone +49212636663
Email anja.pietzke-calcagnile@klinik-bethanien.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Intervention

Diagnostic Test:
magnetic phrenic nerve stimulation
cervical and cortical stimulation of N. Vagus

Locations

Country Name City State
Germany Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V. Solingen Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor Collaborator
Wissenschaftliches Institut Bethanien e.V

Country where clinical trial is conducted

Germany, 

Outcome

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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