ClinicalTrials.gg
RecruitingNCT03854058Updated Dec 15, 2023

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

An observational study in Obesity Hypoventilation Syndrome, sponsored by Wissenschaftliches Institut Bethanien e.V. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by Wissenschaftliches Institut Bethanien e.V · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started May 2019; still recruiting 7 years 6 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 80 Years
Sex
All
01

Study 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
02

Conditions studied

  • Obesity Hypoventilation Syndrome
03

In context

Obesity Hypoventilation Syndrome

73 studies on the registry are indexed under Obesity Hypoventilation Syndrome; 10 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 25 observational studies indexed under Obesity Hypoventilation Syndrome.

Browse Obesity Hypoventilation Syndrome studies →

Lead sponsor

Wissenschaftliches Institut Bethanien e.V is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with OHS or OHS-risk

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with > 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

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testmagnetic phrenic nerve stimulation

    cervical and cortical stimulation of N. Vagus

    Also known as: diaphragmatic ultrasound, spirometry, Sleep-studies, capnography

06

What researchers measure

Primary outcomes

  1. Carbon dioxide rebreathing test

    minute volumen (L/min)

    Time frame: 1 day

  2. transdiaphragmatic pressure (non-volitional)

    difference between intraesophageal and intragastral pressure after posterior magnetic stimulation of the phrenic nerves

    Time frame: 1 day

  3. peripheral nervous system (non-volitional)

    electroneurography after posterior magnetic stimulation of the phrenic nerves

    Time frame: 1 day

  4. diaphragmal ultrasound - excursion (non-volitional)

    excursion of the diaphragm

    Time frame: 1 day

  5. diaphragmal ultrasound - thickness (non-volitional)

    thickness of the diaphragm

    Time frame: 1 day

  6. P0.1 (volitional)

    mouth occlusion pressure (kPa)

    Time frame: 1 day

  7. PImax (volitional)

    maximal inspiratory mouth pressure (kPa)

    Time frame: 1 day

Secondary outcomes

  1. Comparison of PImax and transdiaphragmatic pressure

    Correlation between PImax and transdiaphragmatic pressure

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
    Solingen, Nordrhein-Westfalen 42699, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2019 (actual). Primary completion is estimated for Dec 2024, 67 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2019
First posted
Feb 26, 2019
StartActual
May 1, 2019
Primary completionEst.
Dec 2024
CompletionEst.
Dec 2024
Last update
Dec 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03854058
Lead sponsor
Wissenschaftliches Institut Bethanien e.V
Responsible party
Sponsor
First posted
Feb 26, 2019
Start date
May 1, 2019
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Dec 15, 2023

Study contacts

Anja Pietzke-Calcagnile, Dr.
Contact
anja.pietzke-calcagnile@klinik-bethanien.de
+49212636663
Winfried J Randerath, Prof. Dr.
principal investigator · Wissenschaftliches Institut Bethanien e.V

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion