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

Evaluación clínica de Una tecnología Ambulatoria Para diagnóstico Del sueño

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

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Orsina Dessi, MEng; Phone Number: +447721 877020; Email: orsina@acurable.com

Study Locations

• Spain
  • Seville, Spain
    • Recruiting
    • Hospital Virgen Macarena Sevilla
    • Contact: Jesus Gomez Sanchez, Dr; Email: orsina@acurable.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have been referred for suspicion of sleep apnoea

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Acurable Ltd.
• Collaborators: Hospital Universitario Virgen Macarena
• Investigators: Principal Investigator: Jesus Fernando Sanchez Gomez, MD, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 720/19/EC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No