Obesity Hypoventilation Syndrome (OHS)NCT04570540
Obesity in Sleep Medicine - Focusing on OHS Phenotypes
An observational study of Obesity Hypoventilation Syndrome (OHS), run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome (OHS)
- What is being tested?
- Sleep Study, Pulmonary Function Test and Hypercapnic ventilatory response
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 24 Apr 2014to 10 Sep 2019
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Obese patient routinely admitted to sleep lab
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Pneumologie an der Universität zu Köln / Wissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, North Rhine-Westphalia, 42699
About this study
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.
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Being tested
- Sleep Study, Pulmonary Function Test, Hypercapnic ventilatory response, Cardiopulmonary Exercise Test
- Keywords
- Obstructive Sleep Apnea, Sleep Hypoventilation
- Medical subject headings
- Obesity Hypoventilation Syndrome, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep StudyDiagnostic test
Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
Pulmonary Function TestDiagnostic test
Bodyplethysmographic assessment
Hypercapnic ventilatory responseDiagnostic test
Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
Cardiopulmonary Exercise TestDiagnostic test
Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations
| Study group | Role | What they receive |
|---|---|---|
| OSA | Obstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. Receives: Diagnostic Test: Sleep Study; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Cardiopulmonary Exercise Test | |
| OSA+SH | Obstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. Furthermore, co-existing hypoventilation during sleep, defined by the presence of intermittent hypercapnia as measured by transcutaneous capnometry and arterialized capillary blood gas analysis. Receives: Diagnostic Test: Sleep Study; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Cardiopulmonary Exercise Test | |
| OHS | Obstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. Furthermore, co-existing hypoventilation during wakefulness, defined by a PCO2>45mmHg as measured by arterialized capillary blood gas analysis. Receives: Diagnostic Test: Sleep Study; Diagnostic Test: Pulmonary Function Test; Diagnostic Test: Hypercapnic ventilatory response; Diagnostic Test: Cardiopulmonary Exercise Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypercapnic ventilatory response
Measured: Within 48 hours of sleep lab admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start24 Apr 2014
- Primary completion10 Sep 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity Hypoventilation Syndrome (OHS)Studies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Respironics
- Responsible party
- Sponsor
- Investigators
- Winfried J Randerath, Prof. Dr., Principal investigator, Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570540
- Sponsor's protocol ID
- WI_137/2013
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herkenrath SD, Treml M, Hagmeyer L, Matthes S, Randerath WJ. Severity stages of obesity-related breathing disorders - a cross-sectional cohort study. Sleep Med. 2022 Feb;90:9-16. doi: 10.1016/j.sleep.2021.12.015. Epub 2022 Jan 4.
PubMed 35051737
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity in Sleep Medicine - Focusing on OHS Phenotypes
- ClinicalTrials.gov ID
- NCT04570540
- Acronym / sponsor ID
- WI_137/2013
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Keywords
- Obstructive Sleep Apnea, Sleep Hypoventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- Philips Respironics
- Study start
- 24 Apr 2014 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 30 Sep 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSA | – | Diagnostic Test: Sleep Study, Diagnostic Test: Pulmonary Function Test, Diagnostic Test: Hypercapnic ventilatory response, Diagnostic Test: Cardiopulmonary Exercise TestObstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. |
| OSA+SH | – | Diagnostic Test: Sleep Study, Diagnostic Test: Pulmonary Function Test, Diagnostic Test: Hypercapnic ventilatory response, Diagnostic Test: Cardiopulmonary Exercise TestObstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. Furthermore, co-existing hypoventilation during sleep, defined by the presence of intermittent hypercapnia as measured by transcutaneous capnometry and arterialized capillary blood gas analysis. |
| OHS | – | Diagnostic Test: Sleep Study, Diagnostic Test: Pulmonary Function Test, Diagnostic Test: Hypercapnic ventilatory response, Diagnostic Test: Cardiopulmonary Exercise TestObstructive Sleep Apnea as confirmed by full-night attended in-lab polysomnography showing an apnea-hypopnea index of >=15 per hour or, alternatively, an apnea-hypopnea index >=5 with excessive daytime sleepiness as defined by an Epworth Sleepiness Scale score >9. Furthermore, co-existing hypoventilation during wakefulness, defined by a PCO2>45mmHg as measured by arterialized capillary blood gas analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Obese patient routinely admitted to sleep lab
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Sleep StudyFull-night attended in-lab polysomnography with accompanying transcutaneous capnometry | Diagnostic test | OHS, OSA, OSA+SH |
| Pulmonary Function TestBodyplethysmographic assessment | Diagnostic test | OHS, OSA, OSA+SH |
| Hypercapnic ventilatory responseMeasurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag | Diagnostic test | OHS, OSA, OSA+SH |
| Cardiopulmonary Exercise TestSymptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations | Diagnostic test | OHS, OSA, OSA+SH |
Primary outcome
Hypercapnic ventilatory response
Time frame: Within 48 hours of sleep lab admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Derived from this study: PubMed 35051737Herkenrath SD, Treml M, Hagmeyer L, Matthes S, Randerath WJ. Severity stages of obesity-related breathing disorders - a cross-sectional cohort study. Sleep Med. 2022 Feb;90:9-16. doi: 10.1016/j.sleep.2021.12.015. Epub 2022 Jan 4.
- Individual participant dataSharing planned: No
Related trials for Obesity Hypoventilation Syndrome (OHS)
Not yet recruiting
Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea
Obstructive Sleep Apnea, Obesity (BMI>30)
RecruitingObservational study
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
Bronchial Asthma, Bronchiectasis
Not yet recruiting
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Recruiting
Assessment of Breathing Pattern During NIV
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Not yet recruitingObservational study
Evaluation of Upper Extremity Functions in Obesity Hypoventilation Syndrome Patients
Obesity Hypoventilation Syndrome (OHS)
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
Chief Physician
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 (OHS), 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 30 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypercapnic ventilatory response (time frame: Within 48 hours of sleep lab admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04570540, which also lists 1 linked publication.
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 30 Sep 2020.