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The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. Additionally, the investigators will evaluate Sleepiz One+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. Participants will undergo measurement with Sleepiz One+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with sleep disorders, cardiorespiratory or neuromuscular disorders | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleepiz One+ | Device | Simultaneous sleep study with polysomnography and Sleepiz One+ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiration rate measurement accuracy agreement | 60 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Binary classification of sleep apnea severity based on the AHI > 15 of Sleepiz One+ compared to results of Domino software and data manually scored by sleep technician | 1 Night | |
| Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bartosz Bujan, Dr. med. | Klinik Lengg, Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Lengg AG | Zurich | Switzerland |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Polysomnography | Device | Simultaneous sleep study with polysomnography and Sleepiz One+ |
|
| 60 seconds |
| Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt | 1 Night |
| Average respiration rate agreement between Sleepiz One+ and nasal cannula | 1 Night |
| Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician | 60 seconds |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |