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OpenTrials
Completed

NCT Number: NCT03149744

Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor

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.

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Key information

Conditions

Respiratory Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Similarity to standard of care

    Time frame: One night

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

Secondary outcomes

  1. Qualitative evaluation of RespiraSense

    Time frame: 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

Sponsors and collaborators

Lead sponsor

PMD Solutions

Industry

Collaborators

  • Portsmouth Hospitals NHS Trust

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 11, 2017
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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