NCT02043483

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

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

October 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

2.2 years

First QC Date

November 12, 2013

Last Update Submit

February 16, 2015

Conditions

Obstructive Sleep Apnoea Syndrome

Keywords

CPAPOSASCEDOC (Centro de Estudos de Doenças Crónicas)FCM (Faculdade de Ciências Médicas)UNL (Universidade Nova de LisboaNOVA MEDICAL SCHOOLFCT (Fundação para a Ciência e Tecnologia)

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with clinical improvement

    Treatment efficacy of CPAP will be assessed at the end of treatment through a clinical observation.

    6 months

Secondary Outcomes (1)

  • Frequency of occurence of biomarkers

    6 months

Study Arms (2)

CPAP

Patients with moderate/severe OSAS will be treated with CPAP

Control

Patients with snoring will not be subject to treatment with CPAP

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Obstructive Sleep Apnoea Syndrome Males 25-60 years

You may qualify if:

  • Male
  • years
  • Mild/Moderate/Severe OSAS

You may not qualify if:

  • Female
  • Other sleep disorders
  • Previous CPAP therapy
  • Type 1 diabetes mellitus
  • Familiar Dyslipidemia
  • Severe organ pathology
  • Acute disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Lisboa Norte

Lisbon, Portugal

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Amélia Feliciano, MD

    Centro Hospitalar Lisboa Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2013

First Posted

January 23, 2014

Study Start

October 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 18, 2015

Record last verified: 2015-02

Locations

PT(1)