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Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study

NCT01505959 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 936

Last updated 2014-09-05

No results posted yet for this study

Summary

Targeted population:

Sleep apnea patients at high cardiovascular risk newly treated by CPAP

Hypothesis:

Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

To compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.

Conditions

  • Sleep Apnea Syndromes
  • High Cardiovascular Risk

Interventions

DEVICE

CPAP treatment

Usual CPAP treatment

DEVICE

CPAP treatment

CPAP treatment with telemedicine system

Sponsors & Collaborators

  • Federation of Medical Specialties

    collaborator OTHER

  • Fédération Française de Pneumologie

    lead OTHER

Principal Investigators

  • Jean Louis PEPIN, Prof, PhD · University Hospital, Grenoble, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505959 on ClinicalTrials.gov