Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06029881
Other study ID # B4062023000020
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2023
Est. completion date February 29, 2024

Study information

Verified date September 2023
Source Erasme University Hospital
Contact Paniz Balali
Phone 02 555 32 75 ext +32
Email paniz.balali@ulb.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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 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. 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 (https://ec.europa.eu/tools/eudamed/#/screen/search-device/8d619c90-794a-4564-9a54-829ae fa9c707). 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 47
Est. completion date February 29, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Movesense MD
This device can be attached to the skin (on the chest and center of mass) during sleep using a belt and adhesive electrodes.

Locations

Country Name City State
Belgium Erasme hospital Bruxelles

Sponsors (2)

Lead Sponsor Collaborator
Erasme University Hospital Fonds de la Recherche Scientifique (fnrs)

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 During 1 night (~8hours)
Secondary 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. During 1 night (~8hours)
See also
  Status Clinical Trial Phase
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Recruiting NCT03919955 - A Novel Pharmacological Therapy for Obstructive Sleep Apnea Phase 2
Completed NCT03927547 - Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT01503164 - Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism N/A
Recruiting NCT00747890 - Surgical Treatment of Mild Obstructive Sleep Apnea N/A
Active, not recruiting NCT00738179 - Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease Phase 3
Completed NCT00841906 - Alice PDx User/Validation Extended Trial N/A
Completed NCT00202501 - Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome N/A
Completed NCT00047463 - Effects of Treating Obstructive Sleep Apnea in Epilepsy Phase 2
Recruiting NCT06093347 - Central Apnoea Monitor Study
Terminated NCT05445869 - Severe OSA Study (SOS) N/A
Withdrawn NCT04096261 - The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Recruiting NCT04575740 - Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea N/A
Completed NCT04676191 - Validation of a Contactless Vital Signs Measurement Sensor N/A
Recruiting NCT06015620 - Comorbidities Resolution After MGB Surgery and Change in Body Composition
Completed NCT06051097 - Metabolic Syndrome and Obstructive Sleep Apnea
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
Recruiting NCT05197855 - Sleep Quality Evolution: Dreem Under CPAP N/A