The Development of an Algorithm to Detect Sleep Structure With a Wearable EEG Monitor in an Elderly Population

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Sleep

Treatments: Diagnostic Test: EEG behind the ear

Study type: Interventional

Funder types: Other

Identifiers

NCT04755504

S64190

Details and patient eligibility

About

To evaluate whether it is able to perform sleep staging with EEG data recorded from 2 electrodes behind each ear.

Full description

The Sensor Dot wearable device measures electroencephalography (EEG). It records from 2 electrodes behind each ear. The device was designed as a wearable for seizure detection in epilepsy patients. The purpose of this study is to test its ability to capture the information necessary for sleep monitoring in elderly patients. Trained electrophysiologists are unable to stage sleep on data from novel wearable devices, since AASM sleep scoring rules are only defined for standardized recording positions on the head. Therefore, we need an automated algorithm to perform sleep staging with data from the Sensor Dot device. We will train this algorithm using manual annotations made with the polysomnography simultaneously acquired with the wearable EEG.

Enrollment: 100 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects planned to undergo a diagnostic polysomnography
• > 60y old

Exclusion criteria

• Patients unable to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

EEG evaluation

Experimental group

Description:

All patients will be evaluated during 1 night by standard polysomnography and additionally EEG will be evaluated by 2 electrodes behind each ear connected to a recording device (Sensor Dot)

Treatment:

Diagnostic Test: EEG behind the ear