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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-NO-21-08-037486 | Other Identifier | Eudamed |
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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
| VitalThings | INDUSTRY |
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To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.
A single-center prospective feasibility study. The study device is Somnofy®, a sensor-less commercially available sleep monitor. The ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. The Somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device NOX-T3 and the OSAS event data from the Metronics AirView software from CPAP. Thus, it will be possible to assess if Somnofy® is able to detect the events registered from the diagnostic equipment. For patients started on Continous Positive Airway Pressure (CPAP) treatment, a new registration with Somnofy® will be performed 12 weeks after treatment initiation. The effect of obstructive sleep apnea on patient and partner reported outcomes before and after CPAP initiation will also be assessed through questionnaires and journals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep apnea group | Patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy |
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| Control group | partners of patients with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somnofy® sleep monitor | Device | Registration of sleep score and apneas with radar sensor technology at time of primary investigation and 12 weeks after treatment initiation with continuous positive airway pressure (CPAP) |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea/hypopnea index | Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep score | Objective (AI-based) score of sleep quality from raw data from sleep monitor | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patents with undiagnosed suspected sleep apnea who are referred to Levanger Hospital for respiratory polygraphy, and their partners
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| Name | Affiliation | Role |
|---|---|---|
| Øystein Risa, PhD | NTNU, Fac of Med and Health Sci, Dept of Circulation and Medical Imaging | Study Director |
| Carl Platou, MD | North Trøndelag Hospital Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust | Levanger | Norway |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |