Skip to main content
OpenTrials
Completed

NCT Number: NCT04570540

Obesity in Sleep Medicine - Focusing on OHS Phenotypes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Solingen, North Rhine-Westphalia, 42699, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sleep study

Diagnostic Test

Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry

Pulmonary Function Test

Diagnostic Test

Bodyplethysmographic assessment

Hypercapnic ventilatory response

Diagnostic Test

Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag

cardiopulmonary exercise test

Diagnostic Test

Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations

Primary outcomes

  1. Hypercapnic ventilatory response

    Time frame: Within 48 hours of sleep lab admission

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Collaborators

  • Philips Respironics

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2020
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.