Metabolic SyndromeNCT04839419
Obesity-hypoventilation in Metabolic Syndrom Patients
An observational study of Metabolic Syndrome and Obesity Hypoventilation Syndrome, run by SOS Oxygene Mediterranee at 1 site in France.
Trial summary
The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity Hypoventilation Syndrome, Capnography
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 1 Aug 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be selected as part of their usual care, during a consultation for their respiratory and metabolic monitoring.
Who may be able to join
- BMI>30 kg/m2
- no treatment with CPAP nor NIV
Who cannot join
- obstructive respiratory disease
- non-treated cardiac dysfunction
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique du Château de Vernhes
Bondigoux, 31340
Mathieu Despeaux, MD, 0561372727 ext. +33, m.despeaux@cliniquevernhes.fr
About this study
Official title: Prevalence of Obesity-hypoventilation Syndrome in Patients With Metabolic Syndrome.
The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.
Read the detailed description
After being informed about the study and potential risks, patient agreed to participate and undergo :
a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night.
- Medical subject headings
- Metabolic Syndrome, Obesity Hypoventilation Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Capnia
Arterial pression in CO2 and transcutaneous pression in CO2
Measured: Up to one mont after inclusion
Arterial pression in CO2
PaCO2
Measured: At the inclusion
Secondary outcomes (9)
BMI
body mass index
Measured: At the inclusion
Arterial pression in oxygen
PaO2
Measured: At the inclusion
somnolence
EPWORTH questionnaire; Minimum = 0; Maximum = 24, Higher score means a worth outcome
Measured: At the inclusion
Physical activity level
Ricci\&Gagnon questionnaire, Minimum = 9; Maximum = 45, Higher score means a worth outcome
Measured: At the inclusion
Arterial blood bicarbonates
HCO3-
Measured: At the inclusion
Arterial blood gases
pH
Measured: At the inclusion
Hemoglobin
Hb
Measured: At the inclusion
obstructive sleep apnea items
Apnea-hypopnea index
Measured: Up to one mont after inclusion
Night Oxygen saturation
SpO2
Measured: Up to one mont after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOS Oxygene Mediterranee
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathieu Despeaux, MD, Principal investigator, Clinique du Chateau de Vernhes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839419
- Sponsor's protocol ID
- 2019-A02866-51
- Status last verified
- Nov 2023
- First submitted
- 1 Apr 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obesity-hypoventilation Syndrome in Patients With Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT04839419
- Acronym / sponsor ID
- 2019-A02866-51
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- SOS Oxygene MediterraneeIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 9 Apr 2021 (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.
The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.
Detailed description
After being informed about the study and potential risks, patient agreed to participate and undergo :
a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected as part of their usual care, during a consultation for their respiratory and metabolic monitoring.
Key inclusion criteria (2 listed)
- BMI>30 kg/m2
- no treatment with CPAP nor NIV
Key exclusion criteria (2 listed)
- obstructive respiratory disease
- non-treated cardiac dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Capnia
Time frame: Up to one mont after inclusion
Arterial pression in CO2 and transcutaneous pression in CO2
Arterial pression in CO2
Time frame: At the inclusion
PaCO2
9 secondary outcomes
BMI
Time frame: At the inclusion
Arterial pression in oxygen
Time frame: At the inclusion
somnolence
Time frame: At the inclusion
Physical activity level
Time frame: At the inclusion
Arterial blood bicarbonates
Time frame: At the inclusion
Arterial blood gases
Time frame: At the inclusion
Hemoglobin
Time frame: At the inclusion
obstructive sleep apnea items
Time frame: Up to one mont after inclusion
Night Oxygen saturation
Time frame: Up to one mont after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Mathieu Despeaux, MD principal investigator
Clinique du Chateau de Vernhes
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 Metabolic Syndrome and Obesity Hypoventilation Syndrome, run by SOS Oxygene Mediterranee at 1 site in France.
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 2 inclusion and 2 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 28 Nov 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 France. 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 Delphine Delample, PhD (0612155648 ext. +33, d.delample@sosoxygene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capnia (time frame: Up to one mont after inclusion). The study lists 2 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 28 Nov 2023.