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Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease

NCT ID: NCT03854058

Last Updated: 2023-12-15

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2024-12-31

Brief Summary

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Using an extensive set of both volitional and non-volitional tests of respiratory muscle function and strength it is the aim of this study to

* identify potential determinants for the development of obesity hypoventilation
* to identify predictors for the presence of a sleep-related hypoventilation requiring treatment in obese patients

Detailed Description

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Conditions

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Obesity Hypoventilation Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OHS or elevated OHS-risk (stages 0-IV)

stage 0: OHS-risk (OSA / no hypercapnia)

stage I: obesity associated hypoventilation (intermittent hypercapnia during sleep, arterial carbon dioxide partial pressure (PaCO2) or transcutaneous carbon dioxide partial pressure (PtcCO2) morning \~ evening), bicarbonate \< 27 mmol/L awake)

stage II: obesity associated hypoventilation (intermittent hypercapnia during sleep, PaCO2 or PtcCO2 morning \> evening, bicarbonate ≥ 27 mmol/L awake)

stage III: OHS (hypercapnia, carbon dioxide partial pressure (PCO2) \> 45 mmHg awake)

stage IV: OHS with end organ damage (hypercapnia , PCO2 \> 45 mmHg awake, cardiometabolic comorbidities)

diagnostic tests: magnetic phrenic nerve stimulation, diaphragmatic ultrasound

magnetic phrenic nerve stimulation

Intervention Type DIAGNOSTIC_TEST

cervical and cortical stimulation of N. Vagus

Interventions

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magnetic phrenic nerve stimulation

cervical and cortical stimulation of N. Vagus

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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diaphragmatic ultrasound spirometry Sleep-studies capnography

Eligibility Criteria

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Inclusion Criteria

* patients with BMI \> 30 and obesity-associated hypoventilation stages I - IV
* patients with BMI \> 30 and elevated OHS-risk (= obstructive sleep apnea without hypercapnia)
* age:18-80 years
* capacity to consent

Exclusion Criteria

* any other disease, that causes ventilatory insufficiency
* pacemaker, defibrillators or device for deep brain or vagus nerve stimulation
* esophagitis, Barrett-esophagus, esophageal cancer
* acute gastritis and ulcera ventriculi
* epilepsy
* any medical, psychological or other condition impairing the patient's ability to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wissenschaftliches Institut Bethanien e.V

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Winfried J Randerath, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Wissenschaftliches Institut Bethanien e.V

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

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Anja Pietzke-Calcagnile, Dr.

Role: CONTACT

Phone: +49212636663

Email: [email protected]

Facility Contacts

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Anja Pietzke-Calcagnile

Role: primary

Marcel Treml

Role: backup

Other Identifiers

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WI_18-340

Identifier Type: -

Identifier Source: org_study_id