Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors

Sleep Apnea Clinical Trial

— Screenbeat  

Official title:

Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235984
• Other study ID #: Screenbeat_SA
• Status: Completed
• Start date: July 18, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Firstbeat Technologies Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In this study the feasibility of detecting sleep apnoeas with unobtrusive wearable sensors and sounds recorded with a smartphone is studied by making an overnight recording to patients with high probability of sleep apnoeas. The data acquired with the aforementioned devices is: ECG, acceleration, bioimpedance of thorax and processed and raw audio. In data analysis phase it will be studied which combinations of these signals would enable detecting sleep apnoeas with high enough sensitivity and specificity when compared to a night polygraphy reference (Nox T3 device using airflow, breathing movements, audio, position, movement, oxygen saturation, pulse and leg EMG).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• High a priori probability for SA based on previous PG findings, BMI, and ESS and medical history

• Clinical reason i.e. potential benefit of repeating the PG due to e.g. technical challenges in the previous PG and/or unclear findings or diagnosis. Participation may be offered also in cases where first PG is diagnostic. In these cases accuracy of sleep apnoea grading will be improved.

• Adequate Finnish language skills to comprehend study-related instructions and questionnaires. The study materials are available only in Finnish.

• Signed written informed consent

Exclusion Criteria:

• Medical history of a major cardiovascular event (myocardial infarction, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), stroke, or transient ischemic attack) within the previous 6 months

• Use of cardiac pacemaker or history of atrial fibrillation

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
Finland	KNF-Laboratoriot Oy	Helsinki	Southern Finland

Sponsors (2)

Lead Sponsor	Collaborator
Firstbeat Technologies Oy	CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of apnoea detection using the Screenbeat technology	The sensitivity and specificity of apnoea detection using the Screenbeat technology with different combinations of electrocardiogram (ECG), movement, bioimpedance and audio data, as measured by the AHI (apnoea-hypopnoea events per hour). The clinical reference for SA detection will be provided by PG.	1 day