Obesity in Sleep Medicine - Focusing on OHS Phenotypes

Wissenschaftliches Institut Bethanien e.V

Status: Completed

Conditions: Obesity Hypoventilation Syndrome (OHS)

Treatments: Diagnostic Test: Sleep Study; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Cardiopulmonary Exercise Test; Diagnostic Test: Hypercapnic ventilatory response

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04570540

WI_137/2013

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

82 participants in 3 patient groups

OSA

Description:

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.

Treatment:

Diagnostic Test: Cardiopulmonary Exercise Test

Diagnostic Test: Sleep Study

Diagnostic Test: Pulmonary Function Test

Diagnostic Test: Hypercapnic ventilatory response

OSA+SH

Description:

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.

Treatment:

Diagnostic Test: Cardiopulmonary Exercise Test

Diagnostic Test: Sleep Study

Diagnostic Test: Pulmonary Function Test

Diagnostic Test: Hypercapnic ventilatory response

OHS

Description:

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.

Treatment:

Diagnostic Test: Cardiopulmonary Exercise Test

Diagnostic Test: Sleep Study

Diagnostic Test: Pulmonary Function Test

Diagnostic Test: Hypercapnic ventilatory response