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Clinical Evaluation of a Wearable Sleep Diagnosis Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03544086
Recruitment Status : Completed
First Posted : June 1, 2018
Last Update Posted : December 4, 2020
Sponsor:
Collaborator:
Royal Free Hospital NHS Foundation Trust
Information provided by (Responsible Party):
Acurable Ltd.

Study Description
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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
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
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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 : July 10, 2018
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivities and Specificities for diagnosis of sleep apnoea studies [ Time Frame: 6 months ]
    Sensitivities and Specificities for diagnosis of sleep apnoea studies


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544086


Locations
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United Kingdom
Royal Free Hospital
London, United Kingdom
Sponsors and Collaborators
Acurable Ltd.
Royal Free Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Dr Swapna Mandal, BSc MBBS MRCP SCE, PhD Royal Free NHS Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Acurable Ltd.
ClinicalTrials.gov Identifier: NCT03544086    
Other Study ID Numbers: 225818
225818 ( Other Identifier: IRAS )
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases