Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029881
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-08-16
Brief Title:
Portable System for Non-intrusive Monitoring of Sleep
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
Validation of a New Non-intrusive Technology for Detecting Sleep Apnea
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obstructive sleep apnea OSA is a prevalent kind of sleep-disordered breathing affecting one-seventh of the worlds population Almost 45 percent of this population suffers from mild to severe apnea However in many cases it remains undiagnosed leading to increased health risks Sleep-disordered breathing as seen in OSA can have serious long-term consequences including sympathetic nervous system activation sleep disturbances heart remodeling and cardiovascular disease development
Polysomnography is the standard method for assessing sleep-breathing disorders which requires the attachment of various sensors by a trained technician or a healthcare professional However if the diagnosis of OSA depends on referral to a sleep laboratory and if the referral is reliant on symptoms of an OSA syndrome then current screening approaches may exclude a large population of individuals at risk Besides the number of sleep centers and caregivers is limited and the associated costs are high Therefore alternative techniques allowing home monitoring are necessary
The goal of this observational study is to evaluate the accuracy of the Kinocardiography technique in detecting apneic episodes during sleep and comparing the results with the gold standard polysomnography in 47 patients suffering from obstructive sleep apnea We hypothesize that this device is able to detect sleep-disordered breathing events and thus to compute the apnea-hypopnea index with an accuracy that is close to that of the polysomnography
Participants who meet the criteria will be invited to participate in this protocol and do both polysomnography and kinocardiography records simultaneously at night during sleep
Polysomnography is the standard method for assessing sleep-breathing disorders which requires the attachment of various sensors by a trained technician or a healthcare professional However if the diagnosis of OSA depends on referral to a sleep laboratory and if the referral is reliant on symptoms of an OSA syndrome then current screening approaches may exclude a large population of individuals at risk Besides the number of sleep centers and caregivers is limited and the associated costs are high Therefore alternative techniques allowing home monitoring are necessary
The goal of this observational study is to evaluate the accuracy of the Kinocardiography technique in detecting apneic episodes during sleep and comparing the results with the gold standard polysomnography in 47 patients suffering from obstructive sleep apnea We hypothesize that this device is able to detect sleep-disordered breathing events and thus to compute the apnea-hypopnea index with an accuracy that is close to that of the polysomnography
Participants who meet the criteria will be invited to participate in this protocol and do both polysomnography and kinocardiography records simultaneously at night during sleep
Detailed Description:
1 Study Glossary
BCG Ballistocardiography
ECG Electrocardiography
PSG Polysomnography
SCG Seismocardiography
KCG Kinocardiography
2 Monitoring Technique
Ballistocardiography BCG and seismocardiography SCG are two promising technologies for monitoring vital signs during sleep BCG measures body movements caused by blood flow ejection at each cardiac contraction while SCG detects micro-vibrations from heart contractions on the chest surface These low-cost and unobtrusive technologies have been used in various sleep studies showing promise in vital sign recording detecting abnormal breathing episodes and studying the effects of disease and environmental conditions However more research and replication of studies are required for widespread application
Kinocardiography
Kinocardiography KCG is a technique that combines BCG and SCG with electrocardiography ECG The BCG module is placed close to the subjects center of mass in the lumbar vertebrae The SCG module is placed on the sternum beneath the clavicle close to the heart and major blood vessels Each module is a MOVESENSE device that incorporates a three-axis accelerometer and three-axis gyroscope sensor and is attached to the body using standard sticky gel electrodes and a belt The overall system is remotely controlled via a Bluetooth-connected smartphone or tablet This device allows the measurement of the micro-accelerations induced by the cardiac activity at the bodys surface By computing these accelerations it is possible to calculate other parameters such as the kinetic energies associated with the contraction of the heart
Polysomnography
Polysomnography PSG includes various techniques to monitor neurophysiological cardiopulmonary and other physiologic parameters simultaneously PSG uses electroencephalogram electrooculogram electromyogram ECG pulse oximetry airflow and respiratory effort to identify the underlying causes of sleep disturbances
3 Safety Reporting
The MOVESENSE device will be used in this study to collect ECG and signals from accelerometers and gyroscopes Once this data has been collected then the analysis will be conducted within the Erasme hospital This device is a CE-marked medical device httpseceuropaeutoolseudamedscreensearch-device8d619c90-794a-4564-9a54-829aefa9c707
The hazard probability is extremely low and its severity is minimal the only possibility is feeling uncomfortable with the electrodes gel on the skin
If a subject becomes uncomfortable they can call the nurseoperator throughout the measurement and will be able to let the operator know right away if they want to stop the measurement
4 Strategies for participant recruitment
The recruitment will be done among the subjects referred for PSG as required by their medical condition This study will not affect in any manner the regular medical care of the patients admitted to the sleep laboratory Subjects will be recruited within the routine of the sleep laboratory in the Erasme hospital Subjects who meet the criteria will be invited to participate in this protocol and do both PSG and KCG records simultaneously
BCG Ballistocardiography
ECG Electrocardiography
PSG Polysomnography
SCG Seismocardiography
KCG Kinocardiography
2 Monitoring Technique
Ballistocardiography BCG and seismocardiography SCG are two promising technologies for monitoring vital signs during sleep BCG measures body movements caused by blood flow ejection at each cardiac contraction while SCG detects micro-vibrations from heart contractions on the chest surface These low-cost and unobtrusive technologies have been used in various sleep studies showing promise in vital sign recording detecting abnormal breathing episodes and studying the effects of disease and environmental conditions However more research and replication of studies are required for widespread application
Kinocardiography
Kinocardiography KCG is a technique that combines BCG and SCG with electrocardiography ECG The BCG module is placed close to the subjects center of mass in the lumbar vertebrae The SCG module is placed on the sternum beneath the clavicle close to the heart and major blood vessels Each module is a MOVESENSE device that incorporates a three-axis accelerometer and three-axis gyroscope sensor and is attached to the body using standard sticky gel electrodes and a belt The overall system is remotely controlled via a Bluetooth-connected smartphone or tablet This device allows the measurement of the micro-accelerations induced by the cardiac activity at the bodys surface By computing these accelerations it is possible to calculate other parameters such as the kinetic energies associated with the contraction of the heart
Polysomnography
Polysomnography PSG includes various techniques to monitor neurophysiological cardiopulmonary and other physiologic parameters simultaneously PSG uses electroencephalogram electrooculogram electromyogram ECG pulse oximetry airflow and respiratory effort to identify the underlying causes of sleep disturbances
3 Safety Reporting
The MOVESENSE device will be used in this study to collect ECG and signals from accelerometers and gyroscopes Once this data has been collected then the analysis will be conducted within the Erasme hospital This device is a CE-marked medical device httpseceuropaeutoolseudamedscreensearch-device8d619c90-794a-4564-9a54-829aefa9c707
The hazard probability is extremely low and its severity is minimal the only possibility is feeling uncomfortable with the electrodes gel on the skin
If a subject becomes uncomfortable they can call the nurseoperator throughout the measurement and will be able to let the operator know right away if they want to stop the measurement
4 Strategies for participant recruitment
The recruitment will be done among the subjects referred for PSG as required by their medical condition This study will not affect in any manner the regular medical care of the patients admitted to the sleep laboratory Subjects will be recruited within the routine of the sleep laboratory in the Erasme hospital Subjects who meet the criteria will be invited to participate in this protocol and do both PSG and KCG records simultaneously
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None