Non-contact Sleep Apnea Identification in Neurological Rehabilitation

Study Overview
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Brief Summary
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To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard diagnostic polygraphy measurement. This easy and comfortable pre-screening (Sleepiz One) should reduce the barrier for ward physicians to request a sleep study. The method could help to overcome the bottleneck of resource-intense procedures. It is simple to carry out and does not disturb the sleep of the patients. The scoring is done according to the AASM Manual Version 2.6. Patients with a confirmed diagnosis will be informed about therapy options by a sleep physician and receive a recommendation for further therapy in the discharge letter from the rehabilitation clinic. The goal of the study is then to evaluate if a non-contact method, the Sleepiz One, presents an opportunity for a fast and easy pre-screening during rehabilitation. Therefore, the precision of binary classification of subjects based on their sleep apnea severity (AHI >= 15) made by Sleepiz One will be compared to PG data manually scored by expert sleep scorers.

Official Title
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Identification of Patients With Clinically Relevant Sleep Apnea With a Contactless Device in Rehabilitation Clinic

Conditions
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Sleep Apnea, Stroke

Intervention / Treatment
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* Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18years Ability and consent to undergo electrophysiological routine assessment Informed Consent as documented by signature In-patients of RehaClinic Bad Zurzach Exclusion Criteria: Previous enrolment into the current study, Enrolment of the investigator, his/her family members, employees and other dependent persons Cardiac pacemaker or another implanted electrical device Women who are pregnant or breastfeeding Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contactless sleep apnea screening vs respiratory polygraphy<br> | Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy<br>* Participants will undergo a screening night with Sleepiz One. and with a cardiorespiratory polygraphy device (Miniscreen, Heinen-Löwenstein). Measurements (Miniscreen, Heinen-Löwenstein) Thoracic respiratory effort: respiration frequency (BR), respiration curve Airflow: respiration frequency (BR), respiration curve Body movement: body position Blood oxygen saturation (SpO2) Pulse Measurements (Sleepiz One): • Movement originating from breathing and heart contractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary classification of the apnea severity | Precision of binary classification of subjects based on their sleep apnea severity (apnea-hypopnea index (AHI) >= 15) made by Sleepiz One, compared to PG data manually scored by expert sleep scorers | 1 night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, sleep apnea, contactless, screening