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| Name | Class |
|---|---|
| Iceni Labs Ltd, Warwickshire, United Kingdom | UNKNOWN |
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Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. In children it may lead to hyperactivity in the day and poor school performance. There are a number of techniques for diagnosing the disorder but they can affect the quality of sleep which sometimes makes them inaccurate. Most are unsuitable for small children who cannot understand the value of the tests and tend to remove the monitoring wires and devices in the night. This study aims to validate a new non contact device "Safescan", based on low power radar technology, which can be put under a bed and record breathing patterns with no measuring device in contact with the sleeper. In this initial study the device will be validated in adults, against the gold standard of polysomnography (PSG) in the sleep laboratory at Royal Papworth Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| discovery and learning cohort | Data from this cohort will be used to develop the software algorithms | ||
| Validation | Data from this cohort will be used to validate the software algorithms |
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| Measure | Description | Time Frame |
|---|---|---|
| Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography | Agreement in AHI +/- 10% between Safescan device and PSG. A comparison will be made between the 2 AHI's for each participant. The proportion in whom there is an agreement within +/- 10% will be reported. | overnight (8-10 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG | Agreement +/- 1 breath per minute between Safescan device and PSG | overnight (8-10 hours) |
| Agreement in recorded body position between Safescan device and PSG |
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Inclusion Criteria:
Exclusion Criteria:
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Patients referred to the sleep laboratory for inpatient polysomnography, irrespective of working or known diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| Ian Smith, MD | Royal Papworth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Papworth Hospital | Cambridge | Cambridgeshire | CB2 0AY | United Kingdom |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Percentage of 1 minute epochs during the the Safescan body position is in agreement with that of the PSG |
| overnight (8-10 hours) |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |