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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03854058
• Other study ID #: WI_18-340
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Syndrome

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