NCT04839419

Brief Summary

The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

April 1, 2021

Last Update Submit

November 21, 2023

Conditions

Metabolic SyndromeObesity Hypoventilation SyndromeCapnography

Outcome Measures

Primary Outcomes (2)

  • Capnia

    Arterial pression in CO2 and transcutaneous pression in CO2

    Up to one mont after inclusion

  • Arterial pression in CO2

    PaCO2

    At the inclusion

Secondary Outcomes (9)

  • BMI

    At the inclusion

  • Arterial pression in oxygen

    At the inclusion

  • somnolence

    At the inclusion

  • Physical activity level

    At the inclusion

  • Arterial blood bicarbonates

    At the inclusion

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • obstructive respiratory disease
  • non-treated cardiac dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique du Château de Vernhes

Bondigoux, 31340, France

RECRUITING

MeSH Terms

Conditions

Metabolic SyndromeObesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition Disorders

Study Officials

  • Mathieu Despeaux, MD

    Clinique du Chateau de Vernhes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Delphine Delample, PhD

CONTACT

0612155648d.delample@sosoxygene.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 9, 2021

Study Start

August 1, 2020

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

FR(1)