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

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).

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorder Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KNF-Laboratoriot Oy

Helsinki, Southern Finland, 00260, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The sensitivity and specificity of apnoea detection using the Screenbeat technology

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Firstbeat Technologies Oy

Industry

Collaborators

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

Registry information

Acronym: Screenbeat

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Feb 11, 2022
Registry last updated: Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed