Respiratory Rate
Conditions
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.
Interventions
DEVICERespiraSense 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
Sponsors
Portsmouth Hospitals NHS Trust
PMD Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Similarity to standard of care | One night | The mean error of the device relative to the overnight polysomnography tests ≥ 10 AHI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed