OSA Homemonitoring

NCT03213236 | Withdrawn

• 1 other identifier: S60319
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Up to now, no studies are available where a comparison has been made between the accuracy of, on the one hand, the gold standard PSG and, on the other hand, a home monitoring sleep apnea-diagnostic system, consisting of a pulse oximeter, and accelerometer, a smartphone for snoring analysis, and a mattress for ballistocardiographic (BCG) recordings. The purpose of this study is twofold. On the one hand, a comparison between the predictive performance of an automated home monitoring system and the gold standard PSG in sleep apnea diagnosis will be performed. The home monitoring system consists of a pulse oximeter, an accelerometer, a smartphone to record ambient sound, and a mattress to record the BCG signal. This system will be provided by KU Leuven and Equilli, two partners that work together with the Sleep Laboratory at UZ Leuven and the group STADIUS of the KU Leuven in the OSA+ project. The system performs automated signal processing and classification in order to determine the presence of sleep apnea events. On the other hand, this study aims to improve the phenotyping of patients suffering from sleep apnea. This task will be first developed using the classical PSG and later an evaluation will be performed on the less obtrusive system.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the homemonitoring system

  Accuracy of the homemonitoring system of apnea/hypopnea index measurement (in comparison with gold standard) polysomnography)

  1 day

Secondary Outcomes (2)

• Cardiovascular risk prediction tool

  1 day

• Apnea/hypopnea index severity

  1 day

Study Arms (1)

OSA Homemonitoring

EXPERIMENTAL

Homemonitoring diagnostic system

Diagnostic Test: Homemonitoring diagnostic system

Interventions

Homemonitoring diagnostic system DIAGNOSTIC_TEST

In addition to the standard full-night diagnostic polysomnography, patients will be evaluated during the same night with a "homemonitoring diagnostic system" that consists out of a pulse oximeter, accelerometer, smartphone for audio recording and a mattress that measures the ballistocardiogram.

OSA Homemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to the sleep lab for a diagnostic polysomnography because of suspicion of sleep apnea will be considered to participate in the trial upon signature of the informed consent.

You may not qualify if:

• Patients younger than 18 years

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Bertien Buyse, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 11, 2017
• Study Start: July 1, 2017
• Primary Completion: September 28, 2020
• Study Completion: September 28, 2020
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)