NCT04803552

Non-contact Sleep Apnea Identification in Neurological Rehabilitation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Sleepiz AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea
• Stroke

Interventions

Type	Name	Description
DEVICE	Overnight sleep study with Sleepiz One and a respiratory polygraphy	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

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2021-03-17
• Last updated: 2022-02-08

Locations

1 site across 1 country: Switzerland