Clinical Evaluation of a Wearable Sleep Diagnosis Technology
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 1, 2018
CompletedStudy Start
First participant enrolled
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2020
CompletedDecember 4, 2020
December 1, 2020
1.5 years
May 22, 2018
December 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivities and Specificities for diagnosis of sleep apnoea studies
Sensitivities and Specificities for diagnosis of sleep apnoea studies
6 months
Study Arms (2)
test group
First group is the first 10 patients
study group
following 150 patients
Eligibility Criteria
Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea, consecutive 160 patients coming to the clinic.
You may qualify if:
- Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acurable Ltd.lead
- Royal Free Hospital NHS Foundation Trustcollaborator
Study Sites (1)
Royal Free Hospital
London, United Kingdom
Related Publications (1)
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.
PMID: 34933855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Swapna Mandal, BSc MBBS MRCP SCE, PhD
Royal Free NHS Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 1, 2018
Study Start
July 10, 2018
Primary Completion
December 30, 2019
Study Completion
September 15, 2020
Last Updated
December 4, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share