Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor

Respiratory Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149744
• Other study ID #: PMD-CS-008
• Status: Completed
• Start date: February 28, 2017
• Est. completion date: May 2, 2017

Study information

• Verified date: August 2018
• Source: PMD Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Rate

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Queen Alexandra Hospital	Portsmouth

Sponsors (2)

Lead Sponsor	Collaborator
PMD Solutions	Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Similarity to standard of care	The mean error of the device relative to the overnight polysomnography tests = 10 AHI	One night
Secondary	Qualitative evaluation of RespiraSense	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	One night