NCT04407949

Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography

Untersuchung Der Übereinstimmung Der Ereigniserkennung Von "prismaLine" Geräten Mit Der Polysomnographie

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Institut für Pneumologie Hagen Ambrock eV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP machines with manual scored polysomnography (PSG).

Detailed description

The evaluation of residual sleep disordered breathing (SDB) in sleep apnea (SA) after initiation of continuous positive airway pressure (CPAP) therapy is important to verify the therapeutic success. In clinical practice, the internal records of CPAP devices are utilized to determine the therapeutic success, during either medical consultations or telemetric observation. This study was designed to evaluate the quality of SDB Event Indices (EI), which are recorded by the CPAP device (Prisma, Löwenstein Medical Technology). The detected events of a manual scored polysomnography (PSG) in the sleep laboratory will be compared with the simultaneously recorded events of the CPAP device. This shall lead to recommendations regarding the situations, and in which degree the event detection of the CPAP devices may be meaningful to determine the therapeutic success of home sleep apnea therapy.

Conditions

• Sleep Apnea Syndromes

Interventions

Type	Name	Description
OTHER	CPAP Treatment	Comparing events from the CPAP device with the events scored in PSG

Timeline

• Start date: 2019-01-17
• Primary completion: 2020-06-08
• Completion: 2020-09-30
• First posted: 2020-05-29
• Last updated: 2020-10-06

Locations

1 site across 1 country: Germany