Obesity Hypoventilation SyndromeNCT03854058
Respiratory Muscle Strength in Patients With Obesity Hypoventilation Syndrome (OHS) or With a Precursor of the Disease
An observational study of Obesity Hypoventilation Syndrome, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome
- What is being tested?
- magnetic phrenic nerve stimulation
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2019to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with OHS or OHS-risk
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, North Rhine-Westphalia, 42699
Anja Pietzke-Calcagnile, 0212636663, institut@klinik-bethanien.de
Marcel Treml, 0212636661, institut@klinik-bethanien.de
About this study
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
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
- Conditions
- Obesity Hypoventilation Syndrome
- Being tested
- magnetic phrenic nerve stimulation
- Medical subject headings
- Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic phrenic nerve stimulationDiagnostic test
Also called diaphragmatic ultrasound, spirometry, Sleep-studies, capnography
cervical and cortical stimulation of N. Vagus
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: magnetic phrenic nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon dioxide rebreathing test
minute volumen (L/min)
Measured: 1 day
transdiaphragmatic pressure (non-volitional)
difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves
Measured: 1 day
peripheral nervous system (non-volitional)
electroneurography after posterior magnetic stimulation of the phrenic nerves
Measured: 1 day
diaphragmal ultrasound - excursion (non-volitional)
excursion of the diaphragm
Measured: 1 day
diaphragmal ultrasound - thickness (non-volitional)
thickness of the diaphragm
Measured: 1 day
P0.1 (volitional)
mouth occlusion pressure (kPa)
Measured: 1 day
PImax (volitional)
maximal inspiratory mouth pressure (kPa)
Measured: 1 day
Secondary outcomes (1)
Comparison of PImax and transdiaphragmatic pressure
Correlation between PImax and transdiaphragmatic pressure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 May 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried J Randerath, Prof. Dr., Principal investigator, Wissenschaftliches Institut Bethanien e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854058
- Sponsor's protocol ID
- WI_18-340
- Status last verified
- Dec 2023
- First submitted
- 20 Feb 2019
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03854058
- Acronym / sponsor ID
- WI_18-340
- Conditions
- Obesity Hypoventilation Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHS or elevated OHS-risk (stages 0-IV) | – | Diagnostic Test: magnetic phrenic nerve stimulationstage 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with OHS or OHS-risk
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic phrenic nerve stimulationAlso: diaphragmatic ultrasound, spirometry, Sleep-studies, capnographycervical and cortical stimulation of N. Vagus | Diagnostic test | OHS or elevated OHS-risk (stages 0-IV) |
Primary outcome
Carbon dioxide rebreathing test
Time frame: 1 day
minute volumen (L/min)
transdiaphragmatic pressure (non-volitional)
Time frame: 1 day
difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves
peripheral nervous system (non-volitional)
Time frame: 1 day
electroneurography after posterior magnetic stimulation of the phrenic nerves
diaphragmal ultrasound - excursion (non-volitional)
Time frame: 1 day
excursion of the diaphragm
diaphragmal ultrasound - thickness (non-volitional)
Time frame: 1 day
thickness of the diaphragm
P0.1 (volitional)
Time frame: 1 day
mouth occlusion pressure (kPa)
PImax (volitional)
Time frame: 1 day
maximal inspiratory mouth pressure (kPa)
1 secondary outcome
Comparison of PImax and transdiaphragmatic pressure
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Obesity Hypoventilation Syndrome
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruiting
Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea
Obstructive Sleep Apnea, Obesity (BMI>30)
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
RecruitingObservational study
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
Childhood Obesity, Morbid Obesity
Not yet recruiting
Prevalence of Nocturnal Hypoventilation in Obese Subjects Fiited With Continuous Positive Airway Pressure for Obstructive Sleep Apnea / Hypopnea Syndrome
Nocturnal Hypoventilation, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried J Randerath, Prof. Dr. principal investigator
Wissenschaftliches Institut Bethanien e.V
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity Hypoventilation Syndrome, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anja Pietzke-Calcagnile, Dr. (+49212636663, anja.pietzke-calcagnile@klinik-bethanien.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbon dioxide rebreathing test (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.