Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.

NCT ID: NCT02876653

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Severe OSA

Patients with severe OSA (AHI \> 30)

Group Type OTHER

Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

Intervention Type OTHER

Blood collection, Bone densitometry and Functional respiratory explorations are a specific interventions of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " healthy volunteers "

Moderate OSA

Patients with moderate OSA (5 \< AHI ≤ 30)

Group Type OTHER

Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

Intervention Type OTHER

Blood collection, Bone densitometry and Functional respiratory explorations are a specific interventions of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " healthy volunteers "

Healthy volunteers

Healthy volunteers (AHI ≤ 5)

Group Type OTHER

Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

Intervention Type OTHER

Blood collection, Bone densitometry and Functional respiratory explorations are a specific interventions of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " healthy volunteers "

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

Blood collection, Bone densitometry and Functional respiratory explorations are a specific interventions of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " healthy volunteers "

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patient:

* Men aged 20 to 65 years
* Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil
* With an AHI \> 5 / h

Healthy volunteers:

* Men aged 20 to 65 years
* With an AHI ≤ 5 / h

Exclusion Criteria

All subjects:

* Known cardiovascular risk: hypertension treated, diabetes treated, dyslipidemia treated,
* Known cardiovascular disease associated (heart failure, rhythm disorder ...)
* Known respiratory diseases
* Known neoplastic pathology, known chronic inflammatory disease
* Psychiatric pathology treated
* Medication
* Not affiliated to the French social health care system
* Major protected person
* Private person of liberty
* People in emergency situation
* Patient refusing to participate in the study
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurent Boyer, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Henri Mondor Hospital

Créteil, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P091110

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.