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Portable System for Non-intrusive Monitoring of Sleep

NCT06029881 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2023-09-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fonds de la Recherche Scientifique (fnrs)

    collaborator UNKNOWN

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Philippe van de Borne · Professor

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06029881 on ClinicalTrials.gov