Non-contact Sleep Apnea Identification in Neurological Rehabilitation

Sponsor

Sleepiz AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04803552

Collaborator

(none)

Enrollment

Location

Arm

16.5

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Stroke	Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

67 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Contactless sleep apnea screening vs respiratory polygraphy	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

Arm

Intervention/Treatment

Experimental: Contactless sleep apnea screening vs respiratory polygraphy

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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