NCT00906958

Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.

Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.

Detailed description

Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Nexus Flow Generator	The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.
DEVICE	VPAP Flow Generator 25	Exiting VPAP Auto 25 Flow Generator with A10 Algorithm

Timeline

• Start date: 2009-05-11
• Primary completion: 2009-06-15
• Completion: 2009-06-15
• First posted: 2009-05-21
• Last updated: 2021-03-22
• Results posted: 2021-03-22

Locations

1 site across 1 country: Australia