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Education Programme on Continuous Positive Airway Pressure Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lai Yuen Kwan Agnes, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01173406
First received: July 27, 2010
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Obstructive Sleep Apnea
Behavioral: CPAP education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of a Brief Motivational Enhancement Education Programme on Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • CPAP usage [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    To examine the efficacy of an education programme in enhancing the adherence of using CPAP.


Secondary Outcome Measures:
  • Daytime Sleepiness [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    To examine the efficacy of an education programme in enhancing the improvement in OSA-related health outcomes


Other Outcome Measures:
  • Self-efficacy measure for Sleep Apnea [ Time Frame: 12-week ] [ Designated as safety issue: No ]
    To examine the efficacy of an education programe in enhancing improvement in adherence-related cognitions


Enrollment: 100
Study Start Date: May 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173406

Locations
Hong Kong
Queen Mary Hospital
Hong Kong Island, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Agnes YK Lai, MSc The University of Hong Kong
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lai Yuen Kwan Agnes, Senior Technical Officer, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01173406     History of Changes
Other Study ID Numbers: HKCTC-1113
Study First Received: July 27, 2010
Last Updated: October 18, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Continuous Positive Airway Pressure treatment
Adherence
Education

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 25, 2014