Non-contact Sleep Apnea Identification in Neurological Rehabilitation
Primary Purpose
Sleep Apnea, Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Overnight sleep study with Sleepiz One and a respiratory polygraphy
Sponsored by
About this trial
This is an interventional screening trial for Sleep Apnea focused on measuring stroke, sleep apnea, contactless, screening
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
Sites / Locations
- KSM Bad ZurzachRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contactless sleep apnea screening vs respiratory polygraphy
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04803552
Brief Title
Non-contact Sleep Apnea Identification in Neurological Rehabilitation
Official Title
Identification of Patients With Clinically Relevant Sleep Apnea With a Contactless Device in Rehabilitation Clinic
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sleepiz AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Stroke
Keywords
stroke, sleep apnea, contactless, screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contactless sleep apnea screening vs respiratory polygraphy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Overnight sleep study with Sleepiz One and a respiratory polygraphy
Intervention Description
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
Primary Outcome Measure Information:
Title
Binary classification of the apnea severity
Description
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
Time Frame
1 night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Acker, Dr.
Phone
+41 56 269 60 20
Email
j.acker@ksm.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Acker, Dr.
Organizational Affiliation
KSM Bad Zurzach
Official's Role
Principal Investigator
Facility Information:
Facility Name
KSM Bad Zurzach
City
Bad Zurzach
State/Province
Aargau
ZIP/Postal Code
5330
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Acker
Email
jens.acker@zurzachcare.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-contact Sleep Apnea Identification in Neurological Rehabilitation
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