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Clinical Trials/NCT04803552
NCT04803552
Unknown
Not Applicable

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

Sleepiz AG1 site in 1 country67 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea
Sponsor
Sleepiz AG
Enrollment
67
Locations
1
Primary Endpoint
Binary classification of the apnea severity
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
August 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sleepiz AG
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Binary classification of the apnea severity

Time Frame: 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

Study Sites (1)

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