Portable System for Non-intrusive Monitoring of Sleep

NCT06029881 | Unknown

• 1 other identifier: B4062023000020
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Sleep Apnea

Keywords

obstructive sleep apnea; Ballistocardiography; Seismocardiography; Polysomnography; sleep assessment

Outcome Measures

Primary Outcomes (1)

• 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.

  During 1 night (~8hours)

Secondary Outcomes (1)

• Variation of kinetic energy during apneic episodes

  During 1 night (~8hours)

Study Arms (1)

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

Device: Movesense MD

Interventions

Movesense MD DEVICE

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

Obstructive sleep apnea patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for complaints of sleep disturbances with no prior treatment for sleep apnea and no known cardiovascular pathologies.

You may qualify if:

• The participants should be adult patients who come to Erasme Hospital's sleep department with complaints about sleep disturbances.
• \< age \<70
• BMI \< 35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead
• Fonds de la Recherche Scientifique (fnrs): collaborator

Study Sites (1)

Erasme hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Philippe van de Borne

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paniz Balali

CONTACT

02 555 32 75 ext +32; paniz.balali@ulb.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 8, 2023
• Study Start: September 20, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)