Clinical Evaluation of a Wearable Sleep Diagnosis Technology

December 3, 2020 updated by: Acurable Ltd.
The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.

Study Overview

Status

Completed

Conditions

Detailed Description

The clinical investigation will be performed at the Royal Free London Hospital. Physiological signals will be pseudo-anonymized and only viewed by the research team.

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea, consecutive 160 patients coming to the clinic.

Description

Inclusion Criteria:

  • Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.

Exclusion Criteria:

  • Age under 18 or over 70 years.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
test group
First group is the first 10 patients
study group
following 150 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivities and Specificities for diagnosis of sleep apnoea studies
Time Frame: 6 months
Sensitivities and Specificities for diagnosis of sleep apnoea studies
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acurable Ltd.

Collaborators

Royal Free Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Dr Swapna Mandal, BSc MBBS MRCP SCE, PhD, Royal Free NHS Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2018

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

September 15, 2020

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (ACTUAL)

June 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225818 (OTHER: IRAS)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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