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

NCT03854058 | Unknown

• 1 other identifier: WI_18-340
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity Hypoventilation Syndrome

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Comparison of PImax and transdiaphragmatic pressure

  1 day

Study Arms (1)

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

Interventions

magnetic phrenic nerve stimulation DIAGNOSTIC_TEST

cervical and cortical stimulation of N. Vagus

Also known as: diaphragmatic ultrasound, spirometry, Sleep-studies, capnography

OHS or elevated OHS-risk (stages 0-IV)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with OHS or OHS-risk

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead

Study Sites (1)

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

Solingen, North Rhine-Westphalia, 42699, Germany

RECRUITING

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Interventions

Spirometry; Polysomnography; Capnography

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• Winfried J Randerath, Prof. Dr.

  Wissenschaftliches Institut Bethanien e.V

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja Pietzke-Calcagnile, Dr.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 26, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)