Cardiovascular Impact of Obstructive Sleep Apnea Treatmen... | NCT00741520

Studies
Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients

NCT00741520

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Oct 28, 2010Estimated

Enrollment

36Actual

Phase

Phase 4

Conditions

Obstructive Sleep Apnea

Interventions

CPAP
CPAP

Countries

Brazil

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

Aug 2008

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

Aug 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Aug 25, 2008

First Submission Date that Met QC Criteria

Aug 25, 2008

First Posted Date

Aug 26, 2008Estimated

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

Oct 27, 2010

Last Update Posted Date

Oct 28, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico	OTHER_GOV

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

Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular disease even in the absence of hypertension. However, there are few data regarding the impact of OSA on the preHypertension and Masked Hypertension in apparently normotensive patients with OSA as well as the impact of treatment with continuous positive airway pressure.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Control group	Device: CPAP
2	Active Comparator	CPAP	Device: CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP	Device	Control - no treatment	1
CPAP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Office Blood Pressure	Evaluation of PreHypertension

Secondary Outcomes

Measure	Description	Time Frame
24 Hour Ambulatory Blood Pressure Monitoring	Evaluation of Masked Hypertension

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe OSA patients

Exclusion Criteria:

Smoking
Sustained Hypertension
Heart failure
Diabetes
Renal diseases
Under use of any medication
Under treatment for OSA

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart Institute (InCor)		São Paulo	São Paulo	05403-904	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D058246	Prehypertension
D059468	Masked Hypertension

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