A Phase 3 interventional study of SPAP and CPAP in Sleep Apnea, Obstructive, sponsored by Fisher and Paykel Healthcare. Completed at 1 site in New Zealand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-08.
Sponsored by Fisher and Paykel Healthcare · Phase 3, Interventional, and Treatment
This single-blind randomised crossover trial aims to compare the efficacy of a novel Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an OSA population, aged over 18.
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.
2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 470 are open to participants now.
This study's enrollment of 74 is above the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard CPAP therapy
Device: CPAP
Novel Auto-CPAP algorithm
Device: SPAP
Novel Auto-algorithm for Auto-CPAP device
Standard CPAP therapy
AHI
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.
Time frame: one post study night (once PSG is scored)
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Fisher and Paykel Healthcare