NCT01943708

Novel Auto-continuous Positive Airway Pressure (CPAP) Validation

A Study to Validate a Novel Auto Continuous Positive Airway Pressure Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DEVICE	SPAP	Novel Auto-algorithm for Auto-CPAP device
DEVICE	CPAP	Standard CPAP therapy

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-09-17
• Last updated: 2014-08-08

Locations

1 site across 1 country: New Zealand