Non-contact Sleep Apnea Identification in Neurological Rehabilitation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803552
• Other study ID #: 20-025-EX-KSM Bad Zurzach
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2022
• Source: Sleepiz AG
• Contact: Jens Acker, Dr.
• Phone: +41 56 269 60 20
• Email: j.acker[@]ksm.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Stroke

Intervention

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

Locations

Country	Name	City	State
Switzerland	KSM Bad Zurzach	Bad Zurzach	Aargau

Sponsors (1)

Lead Sponsor	Collaborator
Sleepiz AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binary classification of the apnea severity	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	1 night