Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

NCT ID: NCT02043483

Last Updated: 2015-02-18

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

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no molecular markers for this physiopathological connection have been identified.

This project aims to determine non-invasive biomarkers that may allow better comprehension of the metabolic consequences of OSAS, as well as assess the effect of Continuous positive airway pressure (CPAP) on these metabolic parameters.

This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems to further explore the mechanisms behind OSAS, as well as the effect of the treatment with CPAP.

Detailed Description

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Conditions

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Obstructive Sleep Apnoea Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CPAP

Patients with moderate/severe OSAS will be treated with CPAP

No interventions assigned to this group

Control

Patients with snoring will not be subject to treatment with CPAP

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male
* 25-60 years
* Mild/Moderate/Severe OSAS

Exclusion Criteria

* Female
* Other sleep disorders
* Previous CPAP therapy
* Type 1 diabetes mellitus
* Familiar Dyslipidemia
* Severe organ pathology
* Acute disease
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centro de Estudos de Doenças Crónicas

OTHER

Sponsor Role collaborator

NOVA Medical School

OTHER

Sponsor Role collaborator

Centro Hospitalar Lisboa Norte

OTHER

Sponsor Role collaborator

Instituto Nacional de Saúde Dr. Ricardo Jorge

UNKNOWN

Sponsor Role collaborator

Biotempo

UNKNOWN

Sponsor Role collaborator

Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role collaborator

Universidade Nova de Lisboa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amélia Feliciano, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Lisboa Norte

Locations

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Centro Hospitalar Lisboa Norte

Lisbon, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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FCM-

Identifier Type: -

Identifier Source: org_study_id

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