Non-contact Sleep Apnea Identification in Neurological Rehabilitation

Not Applicable

• Conditions: Stroke; Sleep Apnea
• Interventions: Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy

• Registration Number: NCT04803552
• Lead Sponsor: Sleepiz AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-17
• Study Start: 2021-04-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-02-08
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contactless sleep apnea screening vs respiratory polygraphy	Overnight sleep study with Sleepiz One and a respiratory polygraphy	-

Primary Outcome Measures

Name	Time	Method
Binary classification of the apnea severity	1 night	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

Trial Locations

Locations (1)

KSM Bad Zurzach; 🇨🇭 Bad Zurzach, Aargau, Switzerland