Conventional vs custom made nasal Continuous Positive Airway Pressure (CPAP) mask for treatment of Obstructive Sleep Apnoea: Pilot study A
Not Applicable
Completed
- Conditions
- Obstructive Sleep Apnoea (OSA)Respiratory - Sleep apnoea
- Registration Number
- ACTRN12621001301853
- Lead Sponsor
- Prof Andrew Chan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
1.Diagnosis of OSA, defined as an AHI of more than 5 events per hour.
2.Recommended for CPAP therapy by a sleep physician.
3.Trialed CPAP therapy, with suboptimal tolerance and compliance (less than 70% of nights with at least 4 hours usage) over a period of at least 4 weeks.
4.Willingness to provide informed consent and willingness to participate and comply with the study requirements.
5.Proficiency in English language.
Exclusion Criteria
1.Significant nasal resistance (i.e., unable to breathe through with the mouth closed).
2.Prior upper airway surgery for OSA.
3.Unstable psychiatric or psychological illness that would prevent accurate reporting.
4.Patient is unable to understand the research project.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence to CPAP treatment measured by the percentage of nights with at least 4 hours usage from the analysis of the downloaded CPAP usage data.[ At the end of 4 weeks post-treatment commencement (i.e., after custom made mask fitting).]
- Secondary Outcome Measures
Name Time Method Amount of mask leak assessed by the average of leaking time per night from the analysis of the downloaded CPAP usage data.[ At the end of 4 weeks post-treatment commencement (i.e., after custom made mask fitting).];OSA control assessed by the average Apnea Hypopnea Index (AHI) from the analysis of the downloaded CPAP usage data.[ At the end of 4 weeks post-treatment commencement (i.e., after custom made mask fitting).];Self-assessment perceived comfort assessed by a questionnaire designed specifically for this study.[ At the end of 4 weeks post-treatment commencement (i.e., after custom made mask fitting).]