Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor

Completed

• Conditions: Respiratory Rate

• Registration Number: NCT03149744
• Lead Sponsor: PMD Solutions

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-28
• Primary Completion: 2017-05-02
• Study Completion: 2017-05-02
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• Patients ≥ 18 Years
• Patients due to undergo home monitoring to investigate presence of sleep apnoeic events
• Patients able to provide informed consent to participate in this investigation

Exclusion Criteria

• Patients with known respiratory disorders that are uncontrolled at the time of the sleep study
• Patients allergic to medical grade skin adhesive
• Patients on long term, oral steroid use
• Pregnant women during second and third trimester
• Patients presently on any sleep disorder therapy
• Patients with any history of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
• Patients with any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Similarity to standard of care	One night	The mean error of the device relative to the overnight polysomnography tests ≥ 10 AHI

Secondary Outcome Measures

Name	Time	Method
Qualitative evaluation of RespiraSense	One night	to qualitatively evaluate the perceptions, values and opinions of the RS Sleep Screener device compared with the comparator to identify potential modifications to improve patient acceptance and to inform future implementation of the device within the NHS setting

Trial Locations

Locations (1)

Queen Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom