Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT04071860
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2019-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study
Sponsor:
Papworth Hospital NHS Foundation Trust
Organization:
Study Overview
Official Title:
Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study.
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: