ClinicalTrials.gg
RecruitingNCT04839419Updated Nov 28, 2023

Obesity-hypoventilation in Metabolic Syndrom Patients

An observational study in Metabolic Syndrome, Obesity Hypoventilation Syndrome and Capnography, sponsored by SOS Oxygene Mediterranee. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by SOS Oxygene Mediterranee · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2020; still recruiting 6 years 3 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 74 studies in Metabolic Syndrome with a site in France — 14 open to participants now, 17 under way, none of them phase 3. Metabolic Syndrome · France.

Planned enrollment
4th of 17
400 · median 158
Started
2020
with 3 others
Observational
17 of 74
5 open now
Primary completion
2025-08
later than 3 of 16 live
Registered
57th of 74
by date

Among the 74 studies in Metabolic Syndrome with a site in France, this one is the 4th largest by planned enrollment of the 17 observational ones that give a count, is one of 4 that started in 2020, is one of 17 observational ones, reaches primary completion later than 3 of the 16 other live ones, and was the 57th registered.

Metabolic Syndrome

2,117 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.

Browse Metabolic Syndrome studies →

Open to participants now

14 of the 74 studies in Metabolic Syndrome with a site in France are open now. Recruiting first, the newest first:

8 more — sign in →

All 14 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 231 Metabolic Syndrome studies recruiting now, 68 (29%) set no upper age limit and 135 (58%) stop at 75 or younger; 20 take children under 18; 80 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 74 studies in Metabolic Syndrome with a site in France, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Metabolic Syndrome
  • Obesity Hypoventilation Syndrome
  • Capnography
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients will be selected as part of their usual care, during a consultation for their respiratory and metabolic monitoring.

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

  • >30 kg/m2
  • no treatment with CPAP nor NIV

Exclusion criteria

Exclusion Criteria:

  • obstructive respiratory disease
  • non-treated cardiac dysfunction
Terms in these criteria, in plain language(1)

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Capnia

    Arterial pression in CO2 and transcutaneous pression in CO2

    Time frame: Up to one mont after inclusion

  2. Arterial pression in CO2

    PaCO2

    Time frame: At the inclusion

Secondary outcomes

  1. BMI

    body mass index

    Time frame: At the inclusion

  2. Arterial pression in oxygen

    PaO2

    Time frame: At the inclusion

  3. somnolence

    EPWORTH questionnaire; Minimum = 0; Maximum = 24, Higher score means a worth outcome

    Time frame: At the inclusion

  4. Physical activity level

    Ricci\&Gagnon questionnaire, Minimum = 9; Maximum = 45, Higher score means a worth outcome

    Time frame: At the inclusion

  5. Arterial blood bicarbonates

    HCO3-

    Time frame: At the inclusion

  6. Arterial blood gases

    pH

    Time frame: At the inclusion

  7. Hemoglobin

    Hb

    Time frame: At the inclusion

  8. obstructive sleep apnea items

    Apnea-hypopnea index

    Time frame: Up to one mont after inclusion

  9. Night Oxygen saturation

    SpO2

    Time frame: Up to one mont after inclusion

07

Study locations

1 of 1 sites recruiting
  • Clinique du Château de Vernhes
    Bondigoux, 31340, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2020 (actual). Primary completion is estimated for Aug 2025, 60 months after the start.

Of 160 observational studies under Metabolic Syndrome, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 106. This study's planned 60 months is above that.

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

Registered
Apr 1, 2021
First posted
Apr 9, 2021
StartActual
Aug 1, 2020
Primary completionEst.
Aug 1, 2025
CompletionEst.
Aug 1, 2025
Last update
Nov 28, 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 Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04839419
Lead sponsor
SOS Oxygene Mediterranee
Responsible party
Sponsor
First posted
Apr 9, 2021
Start date
Aug 1, 2020
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
Nov 28, 2023

Study contacts

Delphine Delample, PhD
Contact
d.delample@sosoxygene.com
0612155648 ext. +33
Mathieu Despeaux, MD
principal investigator · Clinique du Chateau de Vernhes

Oversight

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

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