CPAP Effect on Vascular Function in Obstructive Sleep Apnea

NCT02623088 | Completed

• 2 other identifiers: 38RC14.4222014-A01922-45
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a independent cardio-vascular risk factor. Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study measurements of arterial stiffness, and are strong predictors of late cardiovascular events. This study will compare long term evolution in arterial stiffness (PWV) and endothelial dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Endothelial dysfunction; Arterial stiffness; PAP therapies

Outcome Measures

Primary Outcomes (1)

• Long term evolution in arterial stiffness by pulse wave velocity

  4 to 7 years from baseline assessment

Secondary Outcomes (3)

• Endothelial dysfunction by peripheral arterial tone

  4 to 7 years from baseline assessment

• Parameters of systemic inflammation : CRP us, TNF-α, IL-6 , Leptin in blood sampling

  4 to 7 years from baseline assessment

• Parameters of insulin resistance : glycated hemoglobin (HbA1C), blood sugar, insulin

  4 to 7 years from baseline assessment

Study Arms (1)

PAP therapies

Patients with sleep apnea syndrome treated by CPAP after respiratory and vascular assessment and followed 5-7 years, as part of a clinical research.

Other: PAP Therapies (CPAP)

Interventions

PAP Therapies (CPAP) OTHER

Patients with sleep apnea syndrome treated by PAP Therapies (CPAP) after diagnosis and followed 5-7 years.

Also known as: CPAP

PAP therapies

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sleep apnea syndrome treated by CPAP after diagnosis and followed 5-7 years, as part of a clinical research.

You may qualify if:

• Any patient with a initial visit there is 4-7 years for the VNI-SOH protocol (Réf CPP Sud-Est V: 38/2006/2)
• Male or female patient, aged 20-75 years at the initial visit there is 4 to 7 years;
• Patients with a BMI\> 30kg / m2 at diagnostic;
• Patient affiliated to a social security;
• Having given its written consent to participate in the study.

You may not qualify if:

• Person private of liberty by judicial or administrative decision, person under legal protection measure (pregnant or nursing, patient under guardianship) Article L1121-8
• Patient died or lost sight since the initial visit there 4-7 years

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, 38000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Bank

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean-Louis Pépin, MDPhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: December 7, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

FR (1)