The feasibility and diagnostic value of ambulatory surrogate PSG recordings using the Onera sleep test system

Recruiting

• Conditions: Slaapstoornissen; including nrem parasomnia; sleep disorders; sleep problems

• Registration Number: NL-OMON52112
• Lead Sponsor: Epilepsiecentrum Kempenhaeghe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Patients: Participants with a suspicion of a sleep disorder, who were referred
to Kempenhaeghe sleep center for a clinical PSG. Participants should be above
18 years old. Furthermore, participants must be able to read and speak Dutch.

Exclusion Criteria

Patients: Patients with an established diagnosis of epilepsy, pregnancy,
participants who lack the functional capacity to provide informed consent.
Participants who suffer from clinically relevant neurologic or psychiatric
disorders or other somatic disorder, that influences sleep or is limiting the
ability to adhere to the study procedures (for example schizophrenia or alcohol
abuse), shift-workers, and use of medication influencing sleep. Patients with
high clinical needs, for whom participating in the study would be a too high
burden.

In general, the device should not be used in the following cases:
• Subjects with family history of allergic reactions to adhesives or hydrogels
or have a family history of adhesive skin allergies and subjects with severe
skin conditions such as wounds, burns or on any damaged skin.
• Patients with external cardiac defibrillators, diaphragmatic pacers, or extra
cardiac stimulators
• Or in combination with high-frequency surgical equipment, near strong
magnetic fields or with devices such as MRIs or cardiac stimulators

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For the first primary objective, which is the development and evaluation of an<br /><br>algorithm for automated sleep staging, we will calculate the kappa of the<br /><br>agreement between the automated sleep staging based on the STS measurements and<br /><br>the manual sleep staging based on the gold-standard PSG.<br /><br>Additionally, we will determine the kappa of the agreement between automated<br /><br>sleep staging and manual sleep staging obtained from the Onera STS.<br /><br><br /><br>For the second primary objective, we will assess the proportion of completed<br /><br>night measurements relative to the prescribed ones and the amount of time of<br /><br>analyzable data defined as the data that is eligible for sleep stage scoring</p><br>