Identification of Biomarkers for Obstructive Sleep Apnoea... | NCT02043483

Studies
Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

NCT02043483

Sponsor

Universidade Nova de Lisboa

Status

Completed

Last Update Posted

Feb 18, 2015Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Obstructive Sleep Apnoea Syndrome

Interventions

Not provided

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Nov 12, 2013

First Submission Date that Met QC Criteria

Jan 21, 2014

First Posted Date

Jan 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2015

Last Update Posted Date

Feb 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Universidade Nova de LisboaOTHER

Collaborators

Name	Class
Centro de Estudos de Doenças Crónicas	OTHER
NOVA Medical School	OTHER
Centro Hospitalar Lisboa Norte	OTHER
National Health Institute Dr. Ricardo Jorge

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPAP		Patients with moderate/severe OSAS will be treated with CPAP
Control		Patients with snoring will not be subject to treatment with CPAP

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Frequency of occurence of biomarkers	Using Mass Spectrometric Immunoassay, we will identify which biomarkers have a positive association with long-term treatment effect.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Obstructive Sleep Apnoea Syndrome Males 25-60 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amélia Feliciano, MD	Centro Hospitalar Lisboa Norte	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Hospitalar Lisboa Norte		Lisbon			Portugal

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided