Effect of CPAP Treatment in Women With Moderate-to-severe OSA.

August 17, 2015 updated by: Francisco Campos-Rodriguez

Effect of Continuous Positive Airways Pressure (CPAP) in Women With Moderate-to-severe Obstructive Sleep Apnea (OSA). A Multicenter, Randomized, Controlled Trial.

The purpose of this study is to determine whether Continuous Positive Airways Pressure (CPAP) improves quality of life, cardiovascular (blood pressure) and metabolic profile (glucose and lipid metabolism) in females with moderate-to-severe Obstructive Sleep Apnea (OSA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design: multicenter, open-label, randomized, controlled trial of parallel groups with a final blind evaluation.

Study sites. The following hospitals will participate in the study: Valme (Sevilla), la Fe (Valencia), Virgen del Rocío (Sevilla), Gral Yagüe (Burgos), San Pedro de Alcántara (Cáceres), Dr Peset (Valencia), Severo Ochoa (Madrid), Reina Sofía (Córdoba), Dr Negrín (Las Palmas de Gran Canaria), Virgen de la Victoria (Málaga), Río Hortega (Valladolid), Costa del Sol (Málaga), Marqués de Valdecilla (Santander), Albacete (Albacete), Virgen del Puerto (Cáceres), Puerta de Hierro (Madrid), Consorcio Sanitario de Terrassa (Barcelona), Getafe (Madrid), Gral de Alicante (Alicante), Morales Meseguer (Murcia), Tomelloso (Ciudad Real), and Fundación Jiménez Díaz (Madrid). All centers from Spain.

Methods: consecutive outpatient women aged 18-75 years and referred to the sleep clinics for suspicion of OSA will be studied. They will undergo a diagnostic home respiratory polygraphy, and those diagnosed with moderate-to-severe OSA (AHI ≥15) will be eligible for this study and randomized to optimal CPAP treatment or conservative treatment for 12 weeks. Every women will fulfill a standardized protocol and different quality of life questionnaires. Office blood pressure will be measured. Fasting blood samples will be collected to assess glucose and lipid metabolism. All the measurements will be performed at baseline and after 12 weeks of follow-up. Women will be examined at the time of inclusion, after 4 weeks of follow-up and at the end of follow-up (12 weeks).

149 women with moderate-to-severe OSA need to be enrolled in each study arm, according to the sample size calculated to achieve a clinically significant improvement in the Quebec Sleep Questionnaire. The results will be analyzed both on an intention-to-treat basis and on a per-protocol basis (data only from patients who finish the study and show good adherence to CPAP, defined as an average objective use of at least 4 hours/day).

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41014
        • Hospital Universitario Valme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Moderate-to-severe OSA (Apnea-Hypopnea index ≥15) diagnosed by Home Respiratory Polygraphy.
  • Age between 18-75 years.

Exclusion Criteria:

  • diagnosis of narcolepsy or restless legs syndrome
  • unstable cardiovascular profile (cardiovascular event in the previous 3 months)
  • cancer or life expectancy lower than 1 year
  • uncontrolled psychiatric disorders
  • central sleep apnea (>50% of central events)
  • pregnancy
  • risky jobs and severe hypersomnolence (Epworth >=18) requiring urgent treatment
  • either respiratory failure (SaO2<90% or partial oxygen pressure [pO2] <60 mmHg or Long-term O2 therapy
  • heart failure (New York Heart Association class III-IV)
  • prior CPAP therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Conservative treatment. This group will be receive standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling.
Experimental: Continuous positive airways pressure
Optimal Continuous positive airways pressure treatment every night plus standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling.
Device: Continuous positive airways pressure
Optimal Continuous positive airways pressure treatment every night plus standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in quality of life on the Quebec Sleep Questionnaire (QSQ) at week 12
Time Frame: Baseline, 12 weeks.
Baseline, 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of life on the 12-Item Short Form Health Survey (SF-12) at week 12
Time Frame: baseline, 12 weeks
baseline, 12 weeks
Change from baseline in mood state on the Abbreviated Profile Of Mood States (POMS) at week 12
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks
Change from baseline in sleepiness on the Epworth Sleepiness Score (ESS) at week 12
Time Frame: baseline, 12 weeks
baseline, 12 weeks
Change from baseline in anxiety and depression on the Hospital Anxiety and Depression questionnaire (HAD) at week 12
Time Frame: baseline, 12 weeks
baseline, 12 weeks
Change from baseline in quality of life on the Visual Analogic Scale (VAS) at week 12
Time Frame: baseline, 12 weeks
baseline, 12 weeks
Change from baseline in sleep apnea symptoms at week 12
Time Frame: baseline, 12 weeks
baseline, 12 weeks
Change from baseline in blood pressure at week 12
Time Frame: Baseline, 12 weeks
Change in office blood pressure from baseline at week 12
Baseline, 12 weeks
Change from baseline in glucose metabolism at week 12
Time Frame: baseline, 12 weeks
baseline, 12 weeks
Change from baseline in lipid metabolism at week 12
Time Frame: baseline, 12 weeks
baseline, 12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Number of Participants with CPAP use >= 4 hours/day as a Measure of CPAP adherence
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francisco Campos-Rodriguez

Collaborators

Sociedad Española de Neumología y Cirugía Torácica
Fondo de Investigacion Sanitaria

Investigators

  • Principal Investigator: Francisco Campos-Rodriguez, MD, Sociedad Española de Neumología y Cirugía Torácica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 19, 2014

First Submitted That Met QC Criteria

January 25, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI13/00743

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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