NCT00741520

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 28, 2010

Status Verified

August 1, 2008

Enrollment Period

1.6 years

First QC Date

August 25, 2008

Last Update Submit

October 27, 2010

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaBlood PressurePreHypertensionMasked Hypertension

Outcome Measures

Primary Outcomes (1)

  • Office Blood Pressure

    Evaluation of PreHypertension

Secondary Outcomes (1)

  • 24 Hour Ambulatory Blood Pressure Monitoring

Study Arms (2)

1

PLACEBO COMPARATOR

Control group

Device: CPAP

2

ACTIVE COMPARATOR

CPAP

Device: CPAP

Interventions

CPAPDEVICE

Control - no treatment

1

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Severe OSA patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor)

São Paulo, São Paulo, 05403-904, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructivePrehypertensionMasked Hypertension

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular DiseasesHypertension

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 26, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Study Completion

July 1, 2010

Last Updated

October 28, 2010

Record last verified: 2008-08

Locations

BR(1)