NCT01173406

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

1.9 years

First QC Date

July 27, 2010

Last Update Submit

October 18, 2013

Conditions

Keywords

Continuous Positive Airway Pressure treatmentAdherenceEducation

Outcome Measures

Primary Outcomes (1)

  • CPAP usage

    To examine the efficacy of an education programme in enhancing the adherence of using CPAP.

    12-week

Secondary Outcomes (1)

  • Daytime Sleepiness

    12-week

Other Outcomes (1)

  • Self-efficacy measure for Sleep Apnea

    12-week

Study Arms (2)

Standard care (SC)

SHAM COMPARATOR

Standard care

Behavioral: CPAP education

Extended education (ME+SC)

ACTIVE COMPARATOR

Motivational enhancement education + Standard care

Behavioral: CPAP education

Interventions

CPAP educationBEHAVIORAL

Standard CPAP education plus an session and one telephone follow up

Extended education (ME+SC)Standard care (SC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not suitable for CPAP therapy
  • Previously received CPAP therapy
  • Possesses restrictive and obstructive pulmonary diseases
  • Possesses hypoventilation
  • Under unstable health conditions
  • pregnant
  • History of psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong Island, Hong Kong, Hong Kong

Location

Related Publications (2)

  • Lai AYK, Fong DYT, Lam JCM, Weaver TE, Ip MSM. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial. Chest. 2014 Sep;146(3):600-610. doi: 10.1378/chest.13-2228.

  • Lai AY, Fong DY, Lam JC, Weaver TE, Ip MS. Linguistic and psychometric validation of the Chinese version of the self-efficacy measures for sleep apnea questionnaire. Sleep Med. 2013 Nov;14(11):1192-8. doi: 10.1016/j.sleep.2013.04.023. Epub 2013 Sep 16.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Agnes YK Lai, MSc

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Technical Officer

Study Record Dates

First Submitted

July 27, 2010

First Posted

August 2, 2010

Study Start

May 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations