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

Medtronic

Status: Completed

Conditions: Central Sleep Apnea; Sleep Apnea; Sleep-Disordered Breathing; Obstructive Sleep Apnea

Study type: Observational

Funder types: Industry

Identifiers

NCT00775346

20081155 (Other Identifier)

04212008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects will be referred to the Sleep Lab Center for evaluation of possible sleep-disordered breathing.
• Polysomnography (PSG) is obtained as part of normal, standard clinical practice.
• Subject is able to and willingly signs the informed consent form.

Exclusion criteria

• Subject and/or parent/legal guardian is, in the opinion of the investigator, mentally and/or physically unable to provide informed consent/child assent and/or to complete all requirements of the protocol.
• Subject is currently participating in or has participated in an investigational drug study within seven (7) days of enrollment.

Trial design

92 participants in 1 patient group

Polysomnography (PSG) Subjects

Description:

Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.