Clinical Evaluation of a Wearable Sleep Diagnosis Technology

Sponsor

Acurable Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03544086

Collaborator

Royal Free Hospital NHS Foundation Trust (Other)

150

Enrollment

Location

26.2

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea

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 Design

Study Type:

Observational

Actual Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Evaluation of a Wearable Sleep Diagnosis Technology

Actual Study Start Date :

Jul 10, 2018

Actual Primary Completion Date :

Dec 30, 2019

Actual Study Completion Date :

Sep 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
test group First group is the first 10 patients
study group following 150 patients

Outcome Measures

Primary Outcome Measures

Sensitivities and Specificities for diagnosis of sleep apnoea studies [6 months]
Sensitivities and Specificities for diagnosis of sleep apnoea studies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Free Hospital	London		United Kingdom

Sponsors and Collaborators

Acurable Ltd.
Royal Free Hospital NHS Foundation Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Acurable Ltd.

ClinicalTrials.gov Identifier:

NCT03544086

Other Study ID Numbers:

225818
225818

First Posted:

Jun 1, 2018

Last Update Posted:

Dec 4, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sleep Apnea, Obstructive

Study Results

No Results Posted as of Dec 4, 2020