Clinical Evaluation of a Wearable Sleep Diagnosis Technology
NCT ID: NCT03544086
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2018-07-10
2020-09-15
Brief Summary
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Detailed Description
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The Study will involve patients who will have been referred for diagnosis of sleep apnoea, will aim to determine AcuPebble's positive and negative predictive ratios, sensitivities as specificities. Likelihood ratios for diagnosis of sleep apnoea. Clinical experts will determine patients' diagnostic information using the current diagnostic standards. AcuPebble will also generate diagnostic results independently and automatically. Both set of results will be subsequently compared and the relevant performance metrics listed above will be determined.
Consecutive patients referred for sleep study will be recruited to the study. Patients that are willing to participate will be consented on the day of their sleep study and sent home with both - the Trusts usual multichannel polygraphy and the Acupebble.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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test group
First group is the first 10 patients
No interventions assigned to this group
study group
following 150 patients
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects who are not fluent in English, or who have special communication needs.
* Known allergy to the adhesive dressing.
* Subjects with physical or mental impairments who would not be able to use the new technology on their own.
* Subjects with very loose/saggy skin in the neck area which would unavoidably result on - AcuPebble swinging if moving the neck.
* Subjects with pacemakers.
* exclude patients who have any type of implanted electronic devices (these include patients in ICDs and left ventricular assist devices and loop recorders).
18 Years
70 Years
ALL
No
Sponsors
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Royal Free Hospital NHS Foundation Trust
OTHER
Acurable Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Swapna Mandal, BSc MBBS MRCP SCE, PhD
Role: PRINCIPAL_INVESTIGATOR
Royal Free NHS Hospital
Locations
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Royal Free Hospital
London, , United Kingdom
Countries
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References
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Devani N, Pramono RXA, Imtiaz SA, Bowyer S, Rodriguez-Villegas E, Mandal S. Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study. BMJ Open. 2021 Dec 21;11(12):e046803. doi: 10.1136/bmjopen-2020-046803.
Other Identifiers
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225818
Identifier Type: OTHER
Identifier Source: secondary_id
225818
Identifier Type: -
Identifier Source: org_study_id