Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA) (VARIOUS)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Diagnostic Test: oximetry

Study type: Interventional

Funder types: Other

Identifiers

NCT04675268

s64296

Details and patient eligibility

About

The investigators would like to evaluate the variability of oxygen (and PPG) parameters during 7 nights at home. Oxygen (and PPG) parameters will also be evaluated during 1 night at the hospital (diagnostic polysomnography).

Based on currently developed algorithms, surrogate apnea-hypopnea index (AHI), cardiovascular status and the variability of these parameters will be evaluated.

Full description

The main objective of this trial is to evaluate the variability in nocturnal oxygen (and PPG) parameters during 7 consecutive nights at home and to identify clinical predictors of variability in patients with suspected OSA.

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with suspected OSA with a clinical indication to perform a polysomnography

Exclusion criteria

• Patients younger than 18 yrs
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

7 night home oximetry

Experimental group

Description:

Patients will undergo 7 nights home monitoring with oximetry.

Treatment:

Diagnostic Test: oximetry