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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Rate
• Intervention / Treatment: Device: RespiraSense Sleep Screener

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• United Kingdom
  • Portsmouth, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients due to undergo standard of care home sleep testing

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Similarity to standard of care	The mean error of the device relative to the overnight polysomnography tests ≥ 10 AHI	One night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: PMD Solutions
• Collaborators: Portsmouth Hospitals NHS Trust
• Investigators: Principal Investigator: Anoop Chauhan, Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): May 2, 2017
• Study Completion (Actual): May 2, 2017

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PMD-CS-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No