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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01173406
Other study ID # HKCTC-1113
Secondary ID
Status Completed
Phase N/A
First received July 27, 2010
Last updated October 18, 2013
Start date May 2010
Est. completion date April 2012

Study information

Verified date October 2013
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
CPAP education
Standard CPAP education plus an session and one telephone follow up

Locations

Country Name City State
Hong Kong Queen Mary Hospital Hong Kong Island

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Other Self-efficacy measure for Sleep Apnea To examine the efficacy of an education programe in enhancing improvement in adherence-related cognitions 12-week No
Primary CPAP usage To examine the efficacy of an education programme in enhancing the adherence of using CPAP. 12-week No
Secondary Daytime Sleepiness To examine the efficacy of an education programme in enhancing the improvement in OSA-related health outcomes 12-week No
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