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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04803552

Enrollment

Registered

2021-03-17

Start date

2021-04-15

Completion date

2022-08-31

Last updated

2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Stroke

Keywords

stroke, sleep apnea, contactless, screening

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.

Interventions

DEVICEOvernight 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Switzerland

Contacts

Primary ContactJens Acker, Dr.

j.acker@ksm.ch+41 56 269 60 20

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026