NCT04459182

Brief Summary

Evaluation of miRNA contained in exosomes in obese and OSA patients with endothelial dysfunction evaluated by digital plethysmography (ENDOPAT) compared to obese and OSA patients without endothelial dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2023

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2.5 years

First QC Date

June 30, 2020

Last Update Submit

June 10, 2024

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • miRNA cointained in exosomes

    compare exosome content between obese-OSA patients with endothelial dysfunction and without

    immediately after the consultation

Study Arms (2)

Endothelial dysfunction (DE+)

ACTIVE COMPARATOR

obsese patient with OSA (AHI\>15) and endothelial dysfunction

Diagnostic Test: ENDOPAT

No endothelial dysfunction (DE-)

SHAM COMPARATOR

obsese patient with OSA (AHI\>15) and no endothelial dysfunction

Diagnostic Test: ENDOPAT

Interventions

ENDOPATDIAGNOSTIC_TEST

digital plethysmography

Endothelial dysfunction (DE+)No endothelial dysfunction (DE-)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult subject
  • Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent
  • Subject with OSA (defined by AHI \>15/h)

You may not qualify if:

  • cardiac or vascular desease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frédéric GAGNADOUX

Angers, 49933, France

Location

Study Officials

  • GAGNADOUX Frédéric, PhD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 7, 2020

Study Start

January 14, 2021

Primary Completion

July 6, 2023

Study Completion

July 6, 2023

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)