Central Sleep Apnea, Obstructive Sleep Apnea, Sleep Apnea, Sleep-Disordered Breathing
Conditions
Brief 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.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). | 9 Hours | Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP). |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled from 08/19/2008 to 10/14/2008 from 3 medical clinics in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Polysomnography (PSG) Subjects Subjects who have been prescribed with needing a Polysomnography (PSG) will be enrolled into the study. | 92 |
| Total | 92 |
Baseline characteristics
| Characteristic | Polysomnography (PSG) Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants |
| Age, Continuous | 52.7 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 92 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 |
Outcome results
Primary
Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).
Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP).
Time frame: 9 Hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Polysomnography (PSG) Subjects | Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). | Sensitivity of Automated Assessment | 0.820 Ratio |
| Polysomnography (PSG) Subjects | Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). | Specificity of Automated Assessment | 0.897 Ratio |