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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03854058

Enrollment

Registered

2019-02-26

Start date

2019-05-01

Completion date

2024-12-31

Last updated

2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Hypoventilation Syndrome

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

Interventions

DIAGNOSTIC_TESTmagnetic phrenic nerve stimulation

cervical and cortical stimulation of N. Vagus

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PImax (volitional)	1 day	maximal inspiratory mouth pressure (kPa)
Carbon dioxide rebreathing test	1 day	minute volumen (L/min)
transdiaphragmatic pressure (non-volitional)	1 day	difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves
peripheral nervous system (non-volitional)	1 day	electroneurography after posterior magnetic stimulation of the phrenic nerves
diaphragmal ultrasound - excursion (non-volitional)	1 day	excursion of the diaphragm
diaphragmal ultrasound - thickness (non-volitional)	1 day	thickness of the diaphragm
P0.1 (volitional)	1 day	mouth occlusion pressure (kPa)

Secondary

Measure	Time frame	Description
Comparison of PImax and transdiaphragmatic pressure	1 day	Correlation between PImax and transdiaphragmatic pressure

Countries

Germany

Contacts

Primary ContactAnja Pietzke-Calcagnile, Dr.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026