Sleep ApneaNCT06029881
Portable System for Non-intrusive Monitoring of Sleep
An observational study of Sleep Apnea, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Obstructive sleep apnea (OSA) is a prevalent kind of sleep-disordered breathing affecting one-seventh of the world's 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Movesense MD
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Sep 2023to 29 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted for complaints of sleep disturbances with no prior treatment for sleep apnea and no known cardiovascular pathologies.
Who may be able to join
- The participants should be adult patients who come to Erasme Hospital's sleep department with complaints about sleep disturbances.
- 18 < age <70
- BMI < 35 kg/m2
Who cannot join
- Being under any kind of obstructive sleep apnea treatment (cPAP therapy, etc.)
- Having been diagnosed with Atrial fibrillation, significant valvular heart disease, or ventricular dysfunction
- Age <18 or age > 70
- BMI > 35 kg/m2
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Erasme hospital
Brussels, 1070
Philippe van de Borne, PhD. MD., 02 555 39 60 ext +32, philippe.vandeborne@hubruxelles.be
Paniz Balali, MSc
About this study
Official title: Validation of a New Non-intrusive Technology for Detecting Sleep Apnea
Obstructive sleep apnea (OSA) is a prevalent kind of sleep-disordered breathing affecting one-seventh of the world's 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.
Read more
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.
Read the detailed description
- Study Glossary
- BCG = Ballistocardiography
- ECG = Electrocardiography
- PSG = Polysomnography
- SCG = Seismocardiography
- KCG = Kinocardiography
- 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 subject's 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 body's 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.
- 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 (https://ec.europa.eu/tools/eudamed/#/screen/search-device/8d619c90-794a-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 nurse/operator throughout the measurement and will be able to let the operator know right away if they want to stop the measurement.
- 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.
- Conditions
- Sleep Apnea
- Being tested
- Movesense MD
- Keywords
- obstructive sleep apnea, Ballistocardiography, Seismocardiography, Polysomnography, sleep assessment
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movesense MDDevice
This device can be attached to the skin (on the chest and center of mass) during sleep using a belt and adhesive electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive sleep apnea patients | Patients admitted for complaints of sleep disturbances with no prior significant cardiovascular disease.
Inclusion criteria:
* 18 < age <70
* BMI < 35 kg/m2
Exclusion criteria:
* Being under any kind of OSA treatment (cPAP therapy, etc.)
* Having been diagnosed with Atrial fibrillation, significant valvular heart disease, or ventricular dysfunction
* Age <18 or age > 70
* BMI > 35 kg/m2 Receives: Device: Movesense MD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea
Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea based on the apnea-hypopnea index (AHI) and different grades of severity: AHI<5; 5<AHI<15; 15<AHI<30; 30<AHI.
Measured: During 1 night (~8hours)
Secondary outcomes (1)
Variation of kinetic energy during apneic episodes
Measurement of changes in seismocardiography/ballistocardiography integral of kinetic energy (in mJ.s) during and immediately after an apneic episode.
Measured: During 1 night (~8hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start20 Sep 2023 (estimated)
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Responsible party
- Principal investigator, Philippe Van de Borne, Erasme University Hospital
- Investigators
- Philippe van de Borne, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029881
- Sponsor's protocol ID
- B4062023000020
- Status last verified
- Sep 2023
- First submitted
- 16 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Non-intrusive Technology for Detecting Sleep Apnea
- ClinicalTrials.gov ID
- NCT06029881
- Acronym / sponsor ID
- B4062023000020
- Conditions
- Sleep Apnea
- Keywords
- obstructive sleep apnea, Ballistocardiography, Seismocardiography, Polysomnography, sleep assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a prevalent kind of sleep-disordered breathing affecting one-seventh of the world's 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.
Detailed description
- Study Glossary
- BCG = Ballistocardiography
- ECG = Electrocardiography
- PSG = Polysomnography
- SCG = Seismocardiography
- KCG = Kinocardiography
- 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 subject's 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 body's 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.
- 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 (https://ec.europa.eu/tools/eudamed/#/screen/search-device/8d619c90-794a-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 nurse/operator throughout the measurement and will be able to let the operator know right away if they want to stop the measurement.
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive sleep apnea patients | – | Device: Movesense MDPatients admitted for complaints of sleep disturbances with no prior significant cardiovascular disease. Inclusion criteria: * 18 < age <70 * BMI < 35 kg/m2 Exclusion criteria: * Being under any kind of OSA treatment (cPAP therapy, etc.) * Having been diagnosed with Atrial fibrillation, significant valvular heart disease, or ventricular dysfunction * Age <18 or age > 70 * BMI > 35 kg/m2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for complaints of sleep disturbances with no prior treatment for sleep apnea and no known cardiovascular pathologies.
Key inclusion criteria (3 listed)
- The participants should be adult patients who come to Erasme Hospital's sleep department with complaints about sleep disturbances.
- 18 < age <70
- BMI < 35 kg/m2
Key exclusion criteria (4 listed)
- Being under any kind of obstructive sleep apnea treatment (cPAP therapy, etc.)
- Having been diagnosed with Atrial fibrillation, significant valvular heart disease, or ventricular dysfunction
- Age <18 or age > 70
- BMI > 35 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movesense MDThis device can be attached to the skin (on the chest and center of mass) during sleep using a belt and adhesive electrodes. | Device | Obstructive sleep apnea patients |
Primary outcome
Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea
Time frame: During 1 night (~8hours)
Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea based on the apnea-hypopnea index (AHI) and different grades of severity: AHI<5; 5<AHI<15; 15<AHI<30; 30<AHI.
1 secondary outcome
Variation of kinetic energy during apneic episodes
Time frame: During 1 night (~8hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe van de Borne principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paniz Balali (02 555 32 75 ext +32, paniz.balali@ulb.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of MOVESENSE sensor in detecting patients suffering from apnea (time frame: During 1 night (~8hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.