Novel Auto-continuous Positive Airway Pressure (CPAP) Validation
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|ClinicalTrials.gov Identifier: NCT01943708|
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : August 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Device: SPAP Device: CPAP||Phase 3|
Auto-CPAP devices change therapeutic pressure based on the needs of the patient. Algorithms differ from machine to machine. This single-blind randomised crossover trial aims to compare the efficacy of SPAP (a novel Auto-CPAP algorithm) to conventional CPAP.
Up to 50 patients will be recruited from an OSA population, aged over 18. Participants will consist of male and female patients diagnosed with moderate−severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the Northern X Region Ethics Committee, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to CPAP or SPAP.
The therapeutic pressure will be based on the most recent titration night of each patient. Comparisons between data will be made using a one-tailed t-test for non-inferiority of the SPAP algorithm compared with conventional CPAP therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Study to Validate a Novel Auto Continuous Positive Airway Pressure Therapy|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Active Comparator: Continuous positive airway pressure (CPAP) device.
Standard CPAP therapy
Standard CPAP therapy
Experimental: Auto-CPAP device (SPAP).
Novel Auto-CPAP algorithm
Novel Auto-algorithm for Auto-CPAP device
- AHI [ Time Frame: one post study night (once PSG is scored) ]The apnea hypopnea index (AHI) is a measure of sleep disordered breathing. It will be measured and compared between the two groups. The units are number of events per hour.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943708
|Fisher and Paykel Healthcare Sleep Lab|
|Auckland, New Zealand|