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: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
RECRUITING
Solingen
Contact Information
Primary
Anja Pietzke-Calcagnile, Dr.
anja.pietzke-calcagnile@klinik-bethanien.de
+49212636663
Time Frame
Start Date: 2019-05-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 50
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Wissenschaftliches Institut Bethanien e.V