Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor

NCT03149744 | Completed

• 1 other identifier: PMD-CS-008
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Rate

Outcome Measures

Primary Outcomes (1)

• Similarity to standard of care

  The mean error of the device relative to the overnight polysomnography tests ≥ 10 AHI

  One night

Secondary Outcomes (1)

• Qualitative evaluation of RespiraSense

  One night

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients due to undergo standard of care home sleep testing

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PMD Solutions: lead
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (1)

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

Study Officials

• Anoop Chauhan

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: February 28, 2017
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)