Non-contact Sleep Apnea Identification in Neurological Rehabilitation

Sleepiz

Status: Unknown

Conditions: Stroke; Sleep Apnea

Treatments: Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04803552

20-025-EX-KSM Bad Zurzach

Details and patient eligibility

About

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.

Enrollment: 67 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

67 participants in 1 patient group

Contactless sleep apnea screening vs respiratory polygraphy

Experimental group

Treatment:

Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy