Status:
COMPLETED
Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors
Lead Sponsor:
Firstbeat Technologies Oy
Collaborating Sponsors:
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Conditions:
Sleep Apnea
Sleep Disorder
Eligibility:
All Genders
18-65 years
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 proba...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05235984
Start Date
July 18 2022
End Date
September 30 2023
Last Update
October 11 2023
Active Locations (1)
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1
KNF-Laboratoriot Oy
Helsinki, Southern Finland, Finland, 00260