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The goal of this observational study is to characterize the performance of the SleepView+ home sleep test system for the evaluation of moderate to severe obstructuve sleep apnea (OSA) in adult and pediatric patients (ages 12 and over).
This study is being conducted in patients being evaluated for a sleep disorder who are scheduled to undergo an in lab polysomnigraphic study (PSG), enriching for suspected obstructive sleep apnea. This study will involve two phases:
A - comparison of SleepView+ detection of apneas and hypopneas to simultaneously collected in lab PSG (validation phase) and B - evaluation of the ability of patients to use the SleepView+ system in their home environment without sleep technologist support (usability phase)
Participants will progress from phase A to phase B.
This study is a validation and usability study of the SleepView+ home sleep test for assessing obstructive sleep apnea. The SleepView+ device consists of multiple peripheral sensors that are designed to be placed by patients themselves. The system is intended to be operable by patients without technologist intervention.
The study will first evaluate the ability of SleepView+ to diagnose moderate to severe obstructive sleep apnea, as compared to in lab polysomnography. In a second usability phase, participants will take the SleepView+ device home and record a second night without technologist or expert supervision/assistance. Usability surveys and data quality metrics will be collected to assess the ability of participants (or their caregivers) to successfully operate the device in its intended at-home use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspected OSA | All participants will have clinically suspected obstructive sleep apnea requiring PSG evaluation. The study population will be enriched for suspected moderate to severe obstructive sleep apnea. Participants must enroll prior to completion of their in lab PSG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SleepView+ | Device | Participants will wear the SleepView+ sleep monitor during both their in lab overnight PSG (for validation of apnea and hypopnea detection versus gold-standard clinical in-lab PSG), and then subsequently at home (to assess device usability). |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of moderate to severe obstructive sleep apnea (OSA) | SleepView+ derived apnea and hypopnea (over the total recording time) will be compared to in-lab PSG derived apnea and hypopnea count (over the total recording time) in order to determine the ability of the SleepView+ system to diagnose moderate to severe OSA. The primary endpoint will be positive percent agreement (PPA) and negative percent agreement (NPA) between SleepView+ diagnoses and in lab PSG. The passing criteria will be a lower bound of the 90% confidence interval of PPA exceeding 0.70 and a lower bound of the 90% confidence interval of NPA exceeding 0.70. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Usability metrics | Summary statistics of data quality of Phase B (at home) recordings and usability survey responses will be used to assess device usability. | 5 months |
| Diagnotic accuracy for mild OSA |
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Inclusion Criteria:
Exclusion Criteria:
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Adults and children aged 12+ years with suspected OSA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Redwood Pulmonary Medical Associates | Redwood City | California | 94062 | United States | ||
| Sleep Insights |
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Subgroup analysis will be performed on participants diagnosed with mild OSA (Apnea-Hypopnea Index of 5-15). Identical non-inferiority analyses will be conducted on the apnea and hypopnea indices from SleepView+ as compared to in-lab PSG in this cohort.
| 5 months |
| Diagnostic accuracy for severe OSA | Subgroup analysis will be performed on participants diagnosed with severe OSA (Apnea-Hypopnea Index of >30). Identical non-inferiority analyses will be conducted on the apnea and hypopnea indices from SleepView+ as compared to in-lab PSG in this cohort. | 5 months |
| Rochester |
| New York |
| 14623 |
| United States |
| West Region Sleep Center | Cleveland | Ohio | 44135 | United States |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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