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

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 Overview

• Status: Recruiting
• Conditions: Obesity Hypoventilation Syndrome
• Intervention / Treatment: Diagnostic test: magnetic phrenic nerve stimulation

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Anja Pietzke-Calcagnile, Dr.; Phone Number: +49212636663; Email: anja.pietzke-calcagnile@klinik-bethanien.de

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Solingen, Nordrhein-Westfalen, Germany, 42699
      • Recruiting
      • Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
      • Contact: Anja Pietzke-Calcagnile; Phone Number: 0212636663; Email: institut@klinik-bethanien.de
      • Contact: Marcel Treml; Phone Number: 0212636661; Email: institut@klinik-bethanien.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with OHS or OHS-risk

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

OHS or elevated OHS-risk (stages 0-IV); stage 0: OHS-risk (OSA / no hypercapnia) stage I: obesity associated hypoventilation (intermittent hypercapnia during sleep, arterial carbon dioxide partial pressure (PaCO2) or transcutaneous carbon dioxide partial pressure (PtcCO2) morning ~ evening), bicarbonate < 27 mmol/L awake) stage II: obesity associated hypoventilation (intermittent hypercapnia during sleep, PaCO2 or PtcCO2 morning > evening, bicarbonate ≥ 27 mmol/L awake) stage III: OHS (hypercapnia, carbon dioxide partial pressure (PCO2) > 45 mmHg awake) stage IV: OHS with end organ damage (hypercapnia , PCO2 > 45 mmHg awake, cardiometabolic comorbidities) diagnostic tests: magnetic phrenic nerve stimulation, diaphragmatic ultrasound

Diagnostic test: magnetic phrenic nerve stimulation; cervical and cortical stimulation of N. Vagus; Other Names: spirometry; diaphragmatic ultrasound; Sleep-studies; capnography

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V
• Investigators: Principal Investigator: Winfried J Randerath, Prof. Dr., Wissenschaftliches Institut Bethanien e.V

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Syndrome; Obesity; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: WI_18-340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No