Assessing respiratory muscle strength in patients with obesity hypoventilation syndrome
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
Wissenschaftliches Institut Bethanien e.V · NCT03854058
This study tests how well the breathing muscles work in people with obesity hypoventilation syndrome and those at risk to see what might help them breathe better during sleep.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Wissenschaftliches Institut Bethanien e.V (other) |
| Locations | 1 site (Solingen, Nordrhein-Westfalen) |
| Trial ID | NCT03854058 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate respiratory muscle function and strength in patients with obesity hypoventilation syndrome (OHS) and those at risk for developing the condition. It utilizes both volitional and non-volitional tests to identify factors that may contribute to the onset of OHS and to predict the need for treatment in obese patients experiencing sleep-related hypoventilation. The study involves the use of magnetic phrenic nerve stimulation as part of the assessment process.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with a BMI over 30 and varying stages of obesity-associated hypoventilation.
Not a fit: Patients with other diseases causing ventilatory insufficiency or those with certain medical devices or conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of patients at risk for obesity hypoventilation syndrome.
How similar studies have performed: While this approach is focused on a specific patient population, similar studies assessing respiratory function in obesity have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Solingen, Nordrhein-Westfalen
- Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V. — Solingen, Nordrhein-Westfalen, Germany (RECRUITING)
Study contacts
- Principal investigator: Winfried J Randerath, Prof. Dr. — Wissenschaftliches Institut Bethanien e.V
- Study coordinator: Anja Pietzke-Calcagnile, Dr.
- Email: anja.pietzke-calcagnile@klinik-bethanien.de
- Phone: +49212636663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity Hypoventilation Syndrome