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NCT04570540 Clinical Trial

Obesity in Sleep Medicine - Focusing on OHS Phenotypes

Obesity Hypoventilation Syndrome (OHS) Clinical Trial

Official title:
Obesity in Sleep Medicine - Focusing on OHS Phenotypes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04570540
Other study ID # WI_137/2013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 24, 2014
Est. completion date September 10, 2019

Study information
Verified date September 2020
Source Wissenschaftliches Institut Bethanien e.V
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study focuses on a comprehensive examination of obese patients with sleep-related breathing disorders including patients with OSA, sleep hypoventilation and OHS. The aim of this study is to (1) evaluate characteristics of and differences between severity levels of obesity-related breathing disorders, (2) discuss pathophysiological variables associated with hypoventilation during sleep or at daytime and (3) find functional parameters indicating sleep hypoventilation.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date September 10, 2019
Est. primary completion date September 10, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age =18 years

- BMI = 30 kg/m²

- Indication for sleep lab admission or indication for BiLevel or non-invasive ventilation therapy initiation due to existing hypoventilation/OHS

Exclusion Criteria:

- Age <18 years

- Pregnancy, Lactation

- Any medical, psychological or other condition impairing the patient's ability to provide informed consent.

- Missing informed consent

- Participation in another clinical study

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Sleep Study
Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
• Pulmonary Function Test
Bodyplethysmographic assessment
• Hypercapnic ventilatory response
Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
• Cardiopulmonary Exercise Test
Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations

Locations
Country Name City State
Germany Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V. Solingen Nordrhein-Westfalen

Sponsors (2)
Lead Sponsor Collaborator
Wissenschaftliches Institut Bethanien e.V Philips Respironics

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hypercapnic ventilatory response Within 48 hours of sleep lab admission
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