Obesity in Sleep Medicine - Focusing on OHS Phenotypes

NCT04570540 | Completed

• 1 other identifier: WI_137/2013
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity Hypoventilation Syndrome (OHS)

Keywords

Obstructive Sleep Apnea; Sleep Hypoventilation

Outcome Measures

Primary Outcomes (1)

• Hypercapnic ventilatory response

  Within 48 hours of sleep lab admission

Study Arms (3)

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; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Cardiopulmonary Exercise Test

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; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Cardiopulmonary Exercise Test

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; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Cardiopulmonary Exercise Test

Interventions

Sleep Study DIAGNOSTIC_TEST

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

OHS; OSA; OSA+SH

Pulmonary Function Test DIAGNOSTIC_TEST

Bodyplethysmographic assessment

OHS; OSA; OSA+SH

Hypercapnic ventilatory response DIAGNOSTIC_TEST

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

OHS; OSA; OSA+SH

Cardiopulmonary Exercise Test DIAGNOSTIC_TEST

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

OHS; OSA; OSA+SH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patient routinely admitted to sleep lab

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead
• Philips Respironics: collaborator

Study Sites (1)

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

Solingen, North Rhine-Westphalia, 42699, Germany

Location

Related Publications (1)

• 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.

  PMID: 35051737 DERIVED

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Sleep Apnea, Obstructive

Interventions

Polysomnography; Respiratory Function Tests; Exercise Test

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Ergometry; Investigative Techniques

Study Officials

• Winfried J Randerath, Prof. Dr.

  Chief Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: September 30, 2020
• Study Start: April 24, 2014
• Primary Completion: September 10, 2019
• Study Completion: September 10, 2019
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)