N/A
Completed N=92
A Multi-Center Study to Assess the Performance of Saturation Patterns.
Source: ClinicalTrials.gov NCT00775346 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcomePrimary: Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). — 0.820; 0.897 Ratio
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). |
0.820; 0.897 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00775346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.