Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA)
NCT ID: NCT04675268
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2021-01-26
2025-11-01
Brief Summary
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Based on currently developed algorithms, surrogate apnea-hypopnea index (AHI), cardiovascular status and the variability of these parameters will be evaluated.
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Detailed Description
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Data regarding sleep position, alcohol intake and sleep duration will be evaluated (these parameters could be important to explain variability).
Additional objectives are to compare the parameters measured at home with the parameters measured during an in-hospital polysomnography.
The investigators will also evaluate variability in the surrogate AHI described by the group based on the measurements at home and the impact of multi-night evaluation of oxygen (and PPG) parameters on the recently developed mICS algorithm will be explored.
This study is a first explorative approach for further (multi-site) work to define the burden of OSA associated with cardiovascular or psychofunctional problems.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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7 night home oximetry
Patients will undergo 7 nights home monitoring with oximetry.
oximetry
A CE medical approved polygraphy device (Dreamscan 2 - Medatec) will be used to obtain oximetry (and PPG) data
Interventions
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oximetry
A CE medical approved polygraphy device (Dreamscan 2 - Medatec) will be used to obtain oximetry (and PPG) data
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients not able to read or understand the informed consent content on the purpose of the study, due to visual, intellectual or language issues
* Patients with neuromuscular disease or chest wall disease with suspected hypoventilation
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Bertien Buyse, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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s64296
Identifier Type: -
Identifier Source: org_study_id
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