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Trial record 3 of 32 for:    Recruiting, Not yet recruiting, Available Studies | obesity | stimulation

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

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ClinicalTrials.gov Identifier: NCT03854058
Recruitment Status : Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V

Brief Summary:

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

Condition or disease Intervention/treatment
Obesity Hypoventilation Syndrome Diagnostic Test: magnetic phrenic nerve stimulation

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Measurement of Respiratory Muscle Strength by Using Volitional and Non-volitional Tests in Patients With Obesity Hypoventilation Syndrome (OHS), Obesity-associated Hypoventilation and OHS-Risk-Patients to Evaluate Pathophysiological Determinants and Predictors for the Presence of a Sleep-related Hypoventilation Requiring Treatment in Obese Patients
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Group/Cohort Intervention/treatment
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

Diagnostic Test: magnetic phrenic nerve stimulation
cervical and cortical stimulation of N. Vagus
Other Names:
  • diaphragmatic ultrasound
  • spirometry
  • Sleep-studies
  • capnography




Primary Outcome Measures :
  1. Carbon dioxide rebreathing test [ Time Frame: 1 day ]
    minute volumen (L/min)

  2. transdiaphragmatic pressure (non-volitional) [ Time Frame: 1 day ]
    difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves

  3. peripheral nervous system (non-volitional) [ Time Frame: 1 day ]
    electroneurography after posterior magnetic stimulation of the phrenic nerves

  4. diaphragmal ultrasound - excursion (non-volitional) [ Time Frame: 1 day ]
    excursion of the diaphragm

  5. diaphragmal ultrasound - thickness (non-volitional) [ Time Frame: 1 day ]
    thickness of the diaphragm

  6. P0.1 (volitional) [ Time Frame: 1 day ]
    mouth occlusion pressure (kPa)

  7. PImax (volitional) [ Time Frame: 1 day ]
    maximal inspiratory mouth pressure (kPa)


Secondary Outcome Measures :
  1. Comparison of PImax and transdiaphragmatic pressure [ Time Frame: 1 day ]
    Correlation between PImax and transdiaphragmatic pressure



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with OHS or OHS-risk
Criteria

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

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): NCT03854058


Contacts
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Contact: Anja Pietzke-Calcagnile, Dr. +49212636663 anja.pietzke-calcagnile@klinik-bethanien.de

Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
Investigators
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Principal Investigator: Winfried J Randerath, Prof. Dr. Wissenschaftliches Institut Bethanien e.V

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Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT03854058     History of Changes
Other Study ID Numbers: WI_18-340
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
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
Additional relevant MeSH terms:
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Obesity Hypoventilation Syndrome
Obesity
Hypoventilation
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
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