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

Obstructive Sleep Apnea Clinical Trial

Official title:

Evaluación clínica de Una tecnología Ambulatoria Para diagnóstico Del sueño

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028011
• Other study ID #: 720/19/EC
• Status: Recruiting
• Start date: September 30, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Acurable Ltd.
• Contact: Orsina Dessi, MEng
• Phone: +447721 877020
• Email: orsina[@]acurable.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Novel Wearable device
patient will wear novel wearable device overnight along with normal standard of care

Locations

Country	Name	City	State
Spain	Hospital Virgen Macarena Sevilla	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Acurable Ltd.	Hospital Universitario Virgen Macarena

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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