NCT00850434

Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)

Study of an Improved Automatic CPAP Algorithm for the Treatment of Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare a modified AutoSet algorithm running on research hardware versus the traditional AutoSet algorithm running on an S7 AutoSet Spirit. The study will determine if the modified AutoSet algorithm reacts appropriately to obstructive apnoeas and hypopnoeas and provides suitable levels of positive airway pressure compared to the S7 AutoSet Spirit. The hypothesis is that the modified AutoSet algorithm will be more efficacious than the traditional AutoSet algorithm

Detailed description

Subjects in the trial will spend 2 nights in a sleep laboratory being monitored with a full montage polysomnograph (PSG) with each of the algorithms providing positive airway pressure therapy. The PSG records EEG, EMG, EOG, patient airflow, respiratory effort, blood oxygen saturation, and body position. In a randomised order each subject will spend one night being treated by the modified AutoSet algorithm and a second night being treated by the traditional AutoSet algorithm. The subjects will be blinded to which therapy they are receiving and the scorer of the PSG will also be blinded to which therapy is being used.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
DEVICE	Modified AutoSet Algorithm	The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm
DEVICE	Standard AutoSet Algorithm	The standard AutoSet used for treatment of OSA

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-09-01
• Completion: 2008-11-01
• First posted: 2009-02-25
• Last updated: 2021-02-04

Locations

1 site across 1 country: Australia