NCT00775346

A Multi-Center Study to Assess the Performance of Saturation Patterns.

A Multi-Center Study to Assess the Performance of the Saturation Pattern Detection (SPD) Software Algorithm.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 92 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Centers.

Detailed description

The polysomnograms are clinically indicated studies in patients suspected of having sleep-disordered breathing, including, but not limited to: obstructive sleep apnea, complex sleep apnea and/or central sleep apnea. Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.

Conditions

• Sleep-Disordered Breathing
• Obstructive Sleep Apnea
• Sleep Apnea
• Central Sleep Apnea

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-10-20
• Last updated: 2014-08-07
• Results posted: 2010-06-16

Locations

3 sites across 1 country: United States