Obesity in Sleep Medicine - Focusing on OHS Phenotypes

Completed

• Conditions: Obesity Hypoventilation Syndrome (OHS)
• Interventions: Diagnostic Test: Sleep Study; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Cardiopulmonary Exercise Test

• Registration Number: NCT04570540
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-24
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-10
• Status Verified: 2020-09
• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-29
• Last Update Submitted: 2020-09-29
• Study First Posted: 2020-09-30
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSA	Sleep Study	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.
OSA	Cardiopulmonary Exercise Test	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.
OSA	Pulmonary Function Test	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.
OSA+SH	Pulmonary Function Test	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.
OSA+SH	Hypercapnic ventilatory response	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.
OHS	Pulmonary Function Test	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.
OHS	Cardiopulmonary Exercise Test	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.
OSA+SH	Sleep Study	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.
OHS	Sleep Study	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.
OHS	Hypercapnic ventilatory response	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.
OSA	Hypercapnic ventilatory response	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.
OSA+SH	Cardiopulmonary Exercise Test	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.

Primary Outcome Measures

Name	Time	Method
Hypercapnic ventilatory response	Within 48 hours of sleep lab admission

Trial Locations

Locations (1)

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