Effect of CPAP Treatment in Elderly: Randomized Clinical Trial

February 20, 2014 updated by: Miguel Angel Martinez-Garcia, Hospital Universitario La Fe

OBSTRUCTIVE SLEEP APNEA IN THE ELDERLY. ROLE OF CONTINUOUS POSITIVE AIRWAY PRESSURE TREATMENT. A Randomized Controlled Trial

Rationale: Almost all the information the investigators have about the effect of continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA) comes from randomized clinical trials including only middle-aged patients. Little is know, however, about the effect of CPAP in elderly people with OSA. Objective: To assess the effect of CPAP treatment in elderly patients with severe OSA on clinical, quality-of-life and neurocognitive spheres. Methods and Measurements: Open-label, randomized, multicenter clinical trial of parallel groups with blinded end-point design conducted in 12 Spanish teaching hospitals on a consecutive clinical cohort of elderly (≥ 70 years) patients with confirmed severe OSA (IAH≥ 30) receiving CPAP or no therapy while maintaining their usual control for three months. CPAP titration was performed by an auto CPAP device. A good adherence was set as at least 4 hours/day of CPAP use. Primary endpoint was the measurement of quality of life by the Quebec Sleep questionnaire, which includes diurnal and nocturnal symptoms, hypersomnolence, and social and emotional dimensions. Secondary endpoints include different sleep-related symptoms, presence of anxiety or depression, office blood pressure figures and some neurocognitive tests. Patients were invited to a clinical visit on three occasions to quantify the adherence to CPAP. Intention-to-treat analysis was performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Not needed

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 3

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
      • Valencia, Spain, 461015
        • Hospital Universitario La Fe Valwncia

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were initially eligible for participation in the study if they were aged at least 70 years, had an apnea-hypopnea index (AHI) ≥30 and had signed the informed consent to participate

Exclusion Criteria:

  • Current use of CPAP treatment, central sleep apnea (defined as at least 50% of respiratory events having a pattern of apnea or hypopnea without respiratory effort), respiratory failure (defined as diurnal oxygen saturation below 90%), severe heart failure (NYHA III-IV), a cardiovascular event in the month prior to the inclusion in the study or disabling hypersomnia requiring urgent treatment (defined as an Epworth Sleepiness Scale ≥ 18).

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous Positive Airway Pressure
Continuous Positive Airway Pressure is a device that apply a positive pressure in the airway to avoid its collapse during sleep during three months in this study
Device: Continuous Positive Airway Pressure

CPAP applies a positive pressure into the airway to avoid its collapse during sleep.

The pressure used in each patient is calculate by an auto CPAP device during 3 months. This device calculate the pressure that avoid 95% of sleep-disordered breathing

Other Names:
  • CPAP device from ResMed CO. Sydney.
No Intervention: No intervention
No intervention. No placebo is used. Control group without CPAP treatment during three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Changes in quality baseline from baseline to 3 months after random
Quality of life measure by Quebec Sleep Questionnaire (QSQ). This is an specific sleep questionnaire
Changes in quality baseline from baseline to 3 months after random

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep-related symptoms
Time Frame: Changes in sleep-related symptoms from baseline to three months after random
Snoring Witnessed apnea Choking Hypersomnolence Nocturia Nightmares
Changes in sleep-related symptoms from baseline to three months after random

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive tests
Time Frame: Changes in neurocognitive tests from baseline to three months after random
Trail-Making-Test A Trail-Making-Test B Digital Symbol Test Digit Span Test Hospital Depression and Anxiety test Epworth test
Changes in neurocognitive tests from baseline to three months after random
Office Blood pressure measurements
Time Frame: Changes in blood pressure levels from baseline to three months after random
3 office Systolic blood pressure and diastolic blood pressure
Changes in blood pressure levels from baseline to three months after random

Collaborators and Investigators

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

Sponsor

Hospital Universitario La Fe

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Miguel Angel Martinez Martínez García, MD, PhD, Hospital La Fe Valwncia

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

January 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 18, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT-elderly-OSA

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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