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Obesity in Sleep Medicine - Focusing on OHS Phenotypes

Obesity in Sleep Medicine - Focusing on OHS Phenotypes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04570540
Enrollment
82
Registered
2020-09-30
Start date
2014-04-24
Completion date
2019-09-10
Last updated
2020-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Hypoventilation Syndrome (OHS)

Keywords

Obstructive Sleep Apnea, Sleep Hypoventilation

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.

Interventions

DIAGNOSTIC_TESTSleep Study

Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry

DIAGNOSTIC_TESTPulmonary Function Test

Bodyplethysmographic assessment

Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag

DIAGNOSTIC_TESTCardiopulmonary Exercise Test

Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations

Sponsors

Philips Respironics
CollaboratorINDUSTRY
Wissenschaftliches Institut Bethanien e.V
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Hypercapnic ventilatory responseWithin 48 hours of sleep lab admission

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026