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Obesity in Sleep Medicine - Focusing on OHS Phenotypes

Sponsor
Wissenschaftliches Institut Bethanien e.V (Other)
Overall Status
Completed
CT.gov ID
NCT04570540
Collaborator
Philips Respironics (Industry)
82
Enrollment
1
Location
64.6
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Diagnostic Test: Sleep Study
  • Diagnostic Test: Pulmonary Function Test
  • Diagnostic Test: Hypercapnic ventilatory response
  • Diagnostic Test: Cardiopulmonary Exercise Test

Study Design

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 :
Apr 24, 2014
Actual Primary Completion Date :
Sep 10, 2019
Actual Study Completion Date :
Sep 10, 2019

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Hypercapnic ventilatory response [Within 48 hours of sleep lab admission]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Winfried J Randerath, Prof. Dr., Chief Physician

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier:
NCT04570540
Other Study ID Numbers:
  • WI_137/2013
First Posted:
Sep 30, 2020
Last Update Posted:
Sep 30, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Hypoventilation
Obesity Hypoventilation Syndrome
Obesity

Study Results

No Results Posted as of Sep 30, 2020