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

Obstructive Sleep Apnea Clinical Trial

— SAOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876653
• Other study ID #: P091110
• Status: Completed
• Phase: N/A
• First received: July 31, 2016
• Last updated: August 18, 2016
• Start date: March 2011
• Est. completion date: January 2014

Study information

• Verified date: July 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• 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 "

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telomere length of circulating leukocytes		4 weeks	No
Secondary	Carotid-femoral pulse wave velocity		4 weeks	No
Secondary	Bone density		4 weeks	No
Secondary	Correlation between biological parameters and neuropsychological assessment		4 weeks	No
Secondary	Markers of oxidative stress: Malondialdehyde, heme oxygenase-1		4 weeks	No
Secondary	Markers of inflammation: hs-CRP, IL-6, IL-8, MCP-1		4 weeks	No
Secondary	Markers of growth hormone axis (GH, IGF-1, IGFBP)		4 weeks	No