Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea

Sponsor

Acurable Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04028011

Collaborator

Hospital Universitario Virgen Macarena (Other)

150

Enrollment

Location

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Diagnostic Test: Novel Wearable device

Detailed Description

This clinical trial will test a new wearable device for the diagnosis of Sleep Apnoea against Multi-channel polygraphy and Polysomnography.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluación clínica de Una tecnología Ambulatoria Para diagnóstico Del sueño

Actual Study Start Date :

Sep 30, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
PSG and novel wearable device 75 patients will wear polysomnography at the same time as the Novel wearable device	Diagnostic Test: Novel Wearable device patient will wear novel wearable device overnight along with normal standard of care
PG and novel wearable device 75 patients will wear polygraphy at the same time as the novel wearable device	Diagnostic Test: Novel Wearable device patient will wear novel wearable device overnight along with normal standard of care

Arm

Intervention/Treatment

PSG and novel wearable device

75 patients will wear polysomnography at the same time as the Novel wearable device

Diagnostic Test: Novel Wearable device

patient will wear novel wearable device overnight along with normal standard of care

PG and novel wearable device

75 patients will wear polygraphy at the same time as the novel wearable device

Diagnostic Test: Novel Wearable device

patient will wear novel wearable device overnight along with normal standard of care

Outcome Measures

Primary Outcome Measures

Sensitivities and Specificity for diagnosis of sleep apnoea studies with novel wearable device [6 months]
The study aims to compare the diagnosis result of the novel wearable device against standard of care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 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.
patients between the age of 18 yo and 80 yo

Exclusion Criteria:

who are not fluent in Spanish, or who have special communication needs.
Known allergy to the adhesive dressing.
patients with physical or mental impairments who would not be able to use the new technology on their own.
patients with very loose/saggy skin in the neck area which would unavoidably result on AcuPebble swinging if moving the neck.
patients with pacemakers or who have any type of implanted electronic device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Virgen Macarena Sevilla	Seville		Spain

Sponsors and Collaborators

Acurable Ltd.
Hospital Universitario Virgen Macarena

Investigators

Principal Investigator: Jesus Fernando Sanchez Gomez, MD, Hospital Universitario Virgen Macarena

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Acurable Ltd.

ClinicalTrials.gov Identifier:

NCT04028011

Other Study ID Numbers:

720/19/EC

First Posted:

Jul 22, 2019

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

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 Syndromes

Sleep Apnea, Obstructive

Study Results

No Results Posted as of Feb 16, 2022