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| Name | Class |
|---|---|
| Ziekenhuis Oost-Limburg | OTHER |
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Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor.
The purpose of this prospective validation study is the evaluation of the accuracy of the NightOwl HSAT to derive parameters relevant for the diagnosis of sleep apnea. The NightOwl HSAT comprises a finger or forehead mounted sensor and an automated analytics software. The sensor measures double-wavelength photo-plethysmography and accelerometry. The analytics software automatically interprets the sensor data and derives a measure of sympathetic activation of the autonomic nervous system, oxygen saturation, instantaneous pulse rate and activity. For each patient in the cohort, the AHI derived by the NightOwl will be compared to that of the Type I sleep monitor (in-lab PSG), which will acquire data simultaneously during the diagnostic night of the patient referred to the sleep lab for a polysomnography. On a randomly selected subset of patients, a Type IV sleep monitor will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NightOwl HSAT | Other | Patient undergoes a NightOwl sleep apnea test whilst simultaneously undergoing a sleep study with a Type I sleep monitor (Lab-PSG) and optionally a Type IV sleep monitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NightOwl HSAT | Device | Patient wears the NightOwl sensor device |
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| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors | At the time of the diagnostic night |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep-wake discrimination | Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors | At time of the diagnostic night |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duarte Mendes de Almeida, Ir. | Contact | +32 468 17 27 89 | d.mdealmeida@ectosense.com |
| Name | Affiliation | Role |
|---|---|---|
| Duarte Mendes de Almeida, Ir. | Ectosense NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Recruiting | Genk | Limburg | 3600 | Belgium |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |