NCT03149744

Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor

A Mixed-methods Evaluation of a Novel Apnoea Event Detection Monitor in Comparison to Standard of Care Limited Overnight Polysomnography

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: PMD Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea. With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster. The current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed. Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to participate. The RespiraSense Sleep Screener data is only for comparison purposes and will have no effect on their clinical care. If patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.

Conditions

• Respiratory Rate

Interventions

Type	Name	Description
DEVICE	RespiraSense Sleep Screener	RespiraSense will be worn at the same time as the standard of care SomnoScreen and it's results will be masked to the site team

Timeline

• Start date: 2017-02-28
• Primary completion: 2017-05-02
• Completion: 2017-05-02
• First posted: 2017-05-11
• Last updated: 2018-08-29

Locations

1 site across 1 country: United Kingdom