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Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor

NCT03149744 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2018-08-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Portsmouth Hospitals NHS Trust

    collaborator OTHER_GOV

  • PMD Solutions

    lead INDUSTRY

Principal Investigators

  • Anoop Chauhan · Portsmouth Hospitals NHS Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2017-05-02
Completion
2017-05-02

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03149744 on ClinicalTrials.gov