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Obesity in Sleep Medicine - Focusing on OHS Phenotypes

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ClinicalTrials.gov Identifier: NCT04570540
Recruitment Status : Completed
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V

Study Description
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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.

Condition or disease Intervention/treatment
Obesity Hypoventilation Syndrome (OHS) Diagnostic Test: Sleep Study Diagnostic Test: Pulmonary Function Test Diagnostic Test: Hypercapnic ventilatory response Diagnostic Test: Cardiopulmonary Exercise Test

Study Design
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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Obesity in Sleep Medicine - Focusing on OHS Phenotypes
Actual Study Start Date : April 24, 2014
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : September 10, 2019
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Hypercapnic ventilatory response [ Time Frame: Within 48 hours of sleep lab admission ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Obese patient routinely admitted to sleep lab
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570540


Locations
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Germany
Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, Nordrhein-Westfalen, Germany, 42699
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
Philips Respironics
Investigators
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Principal Investigator: Winfried J Randerath, Prof. Dr. Chief Physician
More Information
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Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT04570540    
Other Study ID Numbers: WI_137/2013
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wissenschaftliches Institut Bethanien e.V:
Obstructive Sleep Apnea
Sleep Hypoventilation
Additional relevant MeSH terms:
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Hypoventilation
Obesity Hypoventilation Syndrome
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Respiratory Insufficiency
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases