Completed

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

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What is being collected

Data Collection

Who is being recruted

Apnea+10

+ Mental Disorders

+ Nervous System Diseases

From 18 to 65 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: July 2022
See protocol details

Summary

Principal SponsorFirstbeat Technologies Oy
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 18, 2022

Actual date on which the first participant was enrolled.

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).

Official TitleTechnical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors
NCT05235984
Principal SponsorFirstbeat Technologies Oy
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaMental DisordersNervous System DiseasesNeurologic ManifestationsRespiration DisordersRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, RespiratorySleep Apnea SyndromesSleep Wake DisordersPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomnias

Criteria

4 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

KNF-Laboratoriot Oy

Helsinki, FinlandOpen KNF-Laboratoriot Oy in Google Maps
CompletedOne Study Center