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

Sponsor

Firstbeat Technologies Oy (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05235984

Collaborator

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement (Industry)

Enrollment

Location

14.5

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Sleep Disorder

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jul 18, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Outcome Measures

Primary Outcome Measures

The sensitivity and specificity of apnoea detection using the Screenbeat technology [1 day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KNF-Laboratoriot Oy	Helsinki	Southern Finland	Finland	00260

Sponsors and Collaborators

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

Investigators

Study Director: Juha K Heiskala, LM, DSc, Neurophysiologist at HUS (Hospital district of Helsinki and Uusimaa) and at KNF-Laboratoriot Oy
Principal Investigator: Ilkka Korhonen, DSc, CTO at Firstbeat Technologies and Associate Professor at Tampere University