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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Polysomnography (PSG) Subjects

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No