Non-contact Sleep Apnea Identification in Neurological Rehabilitation

NCT ID: NCT04803552

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2022-08-31

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.

Conditions

Sleep Apnea; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Contactless sleep apnea screening vs respiratory polygraphy

Group Type: EXPERIMENTAL

Overnight sleep study with Sleepiz One and a respiratory polygraphy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sleepiz AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Acker, Dr.

Role: PRINCIPAL_INVESTIGATOR

KSM Bad Zurzach

Locations

KSM Bad Zurzach

Bad Zurzach, Canton of Aargau, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Jens Acker, Dr.

Role: CONTACT

j.acker@ksm.ch

+41 56 269 60 20

Facility Contacts

Jens Acker

Role: primary

jens.acker@zurzachcare.ch

Other Identifiers

20-025-EX-KSM Bad Zurzach

Identifier Type: -

Identifier Source: org_study_id