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

NCT03854058 — Unknown, 50 participants, Wissenschaftliches Institut Bethanien e.V
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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

RegistryNCT03854058
StatusUnknown
Study typeObservational
Enrollment50 (Estimated)
SponsorWissenschaftliches Institut Bethanien e.V (Other)
ConditionsObesity Hypoventilation Syndrome
Interventionsmagnetic phrenic nerve stimulation (Diagnostic test)
Datesstart 2019-05-01, primary completion 2024-12-01 (estimated), completion 2024-12-01 (estimated), first posted 2019-02-26, last updated 2023-12-15
Locations1 site in Germany

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-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

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+Arms and interventions

ArmTypeInterventionsDescription
OHS or elevated OHS-risk (stages 0-IV)Diagnostic Test: magnetic phrenic nerve stimulationstage 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
  • magnetic phrenic nerve stimulation (Diagnostic test), also known as diaphragmatic ultrasound, spirometry, Sleep-studies, capnography: cervical and cortical stimulation of N. Vagus

+Outcome measures

Primary outcomes

  • 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)
  • PImax (volitional) [1 day]: maximal inspiratory mouth pressure (kPa)

Secondary outcomes

  • Comparison of PImax and transdiaphragmatic pressure [1 day]: Correlation between PImax and transdiaphragmatic pressure

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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)

FacilityCityCountryStatus
Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.Solingen, North Rhine-WestphaliaGermanyRecruiting

+Investigators

My Notes