Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
82 participants
OBSERVATIONAL
2014-04-24
2019-09-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Sleep Study
Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
Pulmonary Function Test
Bodyplethysmographic assessment
Hypercapnic ventilatory response
Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
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.
Sleep Study
Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
Pulmonary Function Test
Bodyplethysmographic assessment
Hypercapnic ventilatory response
Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
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.
Sleep Study
Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
Pulmonary Function Test
Bodyplethysmographic assessment
Hypercapnic ventilatory response
Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
Cardiopulmonary Exercise Test
Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations
Interventions
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Sleep Study
Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
Pulmonary Function Test
Bodyplethysmographic assessment
Hypercapnic ventilatory response
Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
Cardiopulmonary Exercise Test
Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Philips Respironics
INDUSTRY
Wissenschaftliches Institut Bethanien e.V
OTHER
Responsible Party
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Principal Investigators
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Winfried J Randerath, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Chief Physician
Locations
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Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, North Rhine-Westphalia, Germany
Countries
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References
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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.
Other Identifiers
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WI_137/2013
Identifier Type: -
Identifier Source: org_study_id