Education Programme on Continuous Positive Airway Pressure Treatment

October 18, 2013 updated by: Lai Yuen Kwan Agnes, The University of Hong Kong

The Efficacy of a Brief Motivational Enhancement Education Programme on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea: A Randomised Controlled Trial

The purpose of this study is to examine whether an education programme would enhance continuous positive airway pressure (CPAP) adherence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnoea (OSA) is a common sleep disorders associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent both in populations of western and eastern countries. Continuous positive airway pressure (CPAP) therapy is an effective standard treatment and is widely prescribed for patients with OSA. However, the use of CPAP for such patients is disappointingly low. Low patient CPAP adherence limits the effectiveness of treatment. To determine whether there is a need for an extended education programme for the OSA patient in order to improve CPAP usage.

Study Type

Interventional

Enrollment (Actual)

100

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

  • Hong Kong
      • Hong Kong Island, Hong Kong
        • Queen Mary Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18 years or over.
  2. Newly diagnosed of OSA and will be starting CPAP therapy

Exclusion Criteria:

  1. Not suitable for CPAP therapy
  2. Previously received CPAP therapy
  3. Possesses restrictive and obstructive pulmonary diseases
  4. Possesses hypoventilation
  5. Under unstable health conditions
  6. pregnant
  7. History of psychiatric illness

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
Sham Comparator: Standard care (SC)
Standard care
Behavioral: CPAP education
Standard CPAP education plus an session and one telephone follow up
Active Comparator: Extended education (ME+SC)
Motivational enhancement education + Standard care
Behavioral: CPAP education
Standard CPAP education plus an session and one telephone follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP usage
Time Frame: 12-week
To examine the efficacy of an education programme in enhancing the adherence of using CPAP.
12-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daytime Sleepiness
Time Frame: 12-week
To examine the efficacy of an education programme in enhancing the improvement in OSA-related health outcomes
12-week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy measure for Sleep Apnea
Time Frame: 12-week
To examine the efficacy of an education programe in enhancing improvement in adherence-related cognitions
12-week

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Agnes YK Lai, MSc, The University of Hong Kong

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

May 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 30, 2010

First Posted (Estimate)

August 2, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCTC-1113

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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