Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Evaluación clínica de Una tecnología Ambulatoria Para diagnóstico Del sueño
1 other identifier
observational
150
1 country
1
Brief Summary
This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.
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 Sep 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2019
CompletedFirst Posted
Study publicly available on registry
July 22, 2019
CompletedStudy Start
First participant enrolled
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedApril 17, 2024
April 1, 2024
5.3 years
July 18, 2019
April 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivities and Specificity for diagnosis of sleep apnoea studies with novel wearable device
The study aims to compare the diagnosis result of the novel wearable device against standard of care
6 months
Study Arms (2)
PSG and novel wearable device
75 patients will wear polysomnography at the same time as the Novel wearable device
PG and novel wearable device
75 patients will wear polygraphy at the same time as the novel wearable device
Interventions
patient will wear novel wearable device overnight along with normal standard of care
Eligibility Criteria
Patients who have been referred for suspicion of sleep apnoea
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acurable Ltd.lead
- Hospital Universitario Virgen Macarenacollaborator
Study Sites (1)
Hospital Virgen Macarena Sevilla
Seville, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesus Fernando Sanchez Gomez, MD
Hospital Universitario Virgen Macarena
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2019
First Posted
July 22, 2019
Study Start
September 30, 2019
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
April 17, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share