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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2024-12-30

Brief Summary

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

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Detailed Description

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

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PSG and novel wearable device

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

Novel Wearable device

Intervention Type DIAGNOSTIC_TEST

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

Novel Wearable device

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Novel Wearable device

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No