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

NCT05235984 | Completed

• 1 other identifier: Screenbeat_SA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Apnea; Sleep Disorder

Keywords

apnea; apnoea; sleep

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

KNF-Laboratoriot Oy

Helsinki, Southern Finland, 00260, Finland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Wake Disorders; Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Signs and Symptoms, Respiratory

Study Officials

• Juha K Heiskala, LM, DSc

  Neurophysiologist at HUS (Hospital district of Helsinki and Uusimaa) and at KNF-Laboratoriot Oy

  STUDY DIRECTOR

• Ilkka Korhonen, DSc

  CTO at Firstbeat Technologies and Associate Professor at Tampere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 11, 2022
• Study Start: July 18, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

FI (1)