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.

Study Overview

• Status: Completed
• Conditions: Obesity Hypoventilation Syndrome (OHS)
• Intervention / Treatment: Diagnostic test: Sleep Study; Diagnostic test: Pulmonary Function Test; Diagnostic test: Hypercapnic ventilatory response; Diagnostic test: Cardiopulmonary Exercise Test

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Solingen, Nordrhein-Westfalen, Germany, 42699
      • Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Obese patient routinely admitted to sleep lab

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSA; Obstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9.	Diagnostic test: Sleep Study; Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry; Diagnostic test: Pulmonary Function Test; Bodyplethysmographic assessment; Diagnostic test: Hypercapnic ventilatory response; Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag; Diagnostic test: Cardiopulmonary Exercise Test; Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations
OSA+SH; Obstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. Furthermore, co-existing hypoventilation during sleep, defined by the presence of intermittent hypercapnia as measured by transcutaneous capnometry and arterialized capillary blood gas analysis.	Diagnostic test: Sleep Study; Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry; Diagnostic test: Pulmonary Function Test; Bodyplethysmographic assessment; Diagnostic test: Hypercapnic ventilatory response; Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag; Diagnostic test: Cardiopulmonary Exercise Test; Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations
OHS; Obstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. Furthermore, co-existing hypoventilation during wakefulness, defined by a PCO2>45mmHg as measured by arterialized capillary blood gas analysis.	Diagnostic test: Sleep Study; Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry; Diagnostic test: Pulmonary Function Test; Bodyplethysmographic assessment; Diagnostic test: Hypercapnic ventilatory response; Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag; Diagnostic test: Cardiopulmonary Exercise Test; Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hypercapnic ventilatory response	Within 48 hours of sleep lab admission

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V
• Collaborators: Philips Respironics
• Investigators: Principal Investigator: Winfried J Randerath, Prof. Dr., Chief Physician

Publications and helpful links

General Publications

• Herkenrath SD, Treml M, Hagmeyer L, Matthes S, Randerath WJ. Severity stages of obesity-related breathing disorders - a cross-sectional cohort study. Sleep Med. 2022 Feb;90:9-16. doi: 10.1016/j.sleep.2021.12.015. Epub 2022 Jan 4.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2014
• Primary Completion (Actual): September 10, 2019
• Study Completion (Actual): September 10, 2019

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Sleep Hypoventilation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Obesity; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: WI_137/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No