Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor

NCT03149744 — Completed, 127 participants, PMD Solutions

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

Registry	NCT03149744
Status	Completed
Study type	Observational
Enrollment	127 (Actual)
Sponsor	PMD Solutions (Industry); collaborators: Portsmouth Hospitals NHS Trust
Conditions	Respiratory Rate
Interventions	RespiraSense Sleep Screener (Device)
Dates	start 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 in United Kingdom

-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.

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+Arms and interventions

RespiraSense Sleep Screener (Device): 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

+Outcome measures

Primary outcomes

Similarity to standard of care [One night]: The mean error of the device relative to the overnight polysomnography tests ≥ 10 AHI

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Queen Alexandra Hospital	Portsmouth	United Kingdom

+Investigators

Anoop Chauhan, Principal investigator, Portsmouth Hospitals NHS Trust

My Notes

Public

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