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NCT06029881

Portable System for Non-intrusive Monitoring of Sleep

Status unknown Last updated 8 September 2023
What this trial tests

trial testing Movesense MD in Sleep Apnea in 47 participants. Status unknown.

Timeline
20 September 2023
Primary endpoint
29 February 2024
29 February 2024

Quick facts

Lead sponsorErasme University Hospital
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment47
Start date20 September 2023
Primary completion29 February 2024
Estimated completion29 February 2024
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Erasme University Hospital

Who can join

Adults 18 to 70, any sex, with Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Heart rate variability during wakefulness reflects sleep apnea indicators but remains context-dependent.
    Balali P, Omari G, Hossein A, Abdessater E, et al · · 2026 · PMID 41953462 · DOI 10.3389/fphys.2026.1793057

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Other recruiting trials for Sleep Apnea

Currently open trials in the same condition.

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Data sources for this page

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