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

October 10, 2023 updated by: Firstbeat Technologies Oy
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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Southern Finland
      • Helsinki, Southern Finland, Finland, 00260
        • KNF-Laboratoriot Oy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study group will be recruited from occupational health care patients who have been earlier admitted by Mehiläinen for a PG study at KNF-laboratoriot.

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firstbeat Technologies Oy

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Screenbeat_SA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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