Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease

Wissenschaftliches Institut Bethanien e.V50 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity Hypoventilation Syndrome

Interventions

magnetic phrenic nerve stimulationDIAGNOSTIC_TEST

cervical and cortical stimulation of N. Vagus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Solingen, North Rhine-Westphalia, Germany

RECRUITING

Outcomes

Primary Outcomes

Carbon dioxide rebreathing test

minute volumen (L/min)

Time frame: 1 day

transdiaphragmatic pressure (non-volitional)

difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves

Time frame: 1 day

peripheral nervous system (non-volitional)

electroneurography after posterior magnetic stimulation of the phrenic nerves

Time frame: 1 day

diaphragmal ultrasound - excursion (non-volitional)

excursion of the diaphragm

Time frame: 1 day

diaphragmal ultrasound - thickness (non-volitional)

thickness of the diaphragm

Time frame: 1 day

P0.1 (volitional)

mouth occlusion pressure (kPa)

Time frame: 1 day

PImax (volitional)

maximal inspiratory mouth pressure (kPa)

Time frame: 1 day

Secondary Outcomes

Comparison of PImax and transdiaphragmatic pressure

Correlation between PImax and transdiaphragmatic pressure

Time frame: 1 day

Central Contacts

Anja Pietzke-Calcagnile, Dr.

CONTACT

+49212636663 anja.pietzke-calcagnile@klinik-bethanien.de

Data from ClinicalTrials.gov

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