NCT02876653

Brief 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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

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

Study Start

First participant enrolled

March 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
Last Updated

August 24, 2016

Status Verified

July 1, 2016

Enrollment Period

2.8 years

First QC Date

July 31, 2016

Last Update Submit

August 18, 2016

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaAgingTelomere length

Outcome Measures

Primary Outcomes (1)

  • Telomere length of circulating leukocytes

    4 weeks

Secondary Outcomes (6)

  • Carotid-femoral pulse wave velocity

    4 weeks

  • Bone density

    4 weeks

  • Correlation between biological parameters and neuropsychological assessment

    4 weeks

  • Markers of oxidative stress: Malondialdehyde, heme oxygenase-1

    4 weeks

  • Markers of inflammation: hs-CRP, IL-6, IL-8, MCP-1

    4 weeks

  • +1 more secondary outcomes

Study Arms (3)

Severe OSA

OTHER

Patients with severe OSA (AHI \> 30)

Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

Moderate OSA

OTHER

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

Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

Healthy volunteers

OTHER

Healthy volunteers (AHI ≤ 5)

Other: Polysomnography , blood collection, bone densitometry and Functional respiratory explorations

Interventions

Polysomnography , blood collection, bone densitometry and Functional respiratory explorationsOTHER

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 volunteersModerate OSASevere OSA

Eligibility Criteria

Age20 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Laurent Boyer, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 24, 2016

Study Start

March 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 24, 2016

Record last verified: 2016-07

Locations

FR(1)