Back to resultsValidation of a Contactless Vital Signs Measurement Sensor
Primary Purpose
Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Sleepiz One+
Polysomnography
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea focused on measuring respiration, sleep
Eligibility Criteria
Inclusion Criteria:
- Age >18years
- Ability and consent to undergo electrophysiological routine assessment
- Informed Consent as documented by signature
- Patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders
- Ambulatory or stationary patients of Klinik Lengg
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
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
Sites / Locations
- Klinik Lengg AG
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with sleep disorders, cardiorespiratory or neuromuscular disorders
Arm Description
Outcomes
Primary Outcome Measures
Respiration rate measurement accuracy agreement
Secondary Outcome Measures
Binary classification of sleep apnea severity based on the AHI > 15 of Sleepiz One+ compared to results of Domino software and data manually scored by sleep technician
Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula
Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt
Average respiration rate agreement between Sleepiz One+ and nasal cannula
Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04676191
Brief Title
Validation of a Contactless Vital Signs Measurement Sensor
Official Title
Single- Center Performance Assessment of a Contactless Sensor for Vital Physiological Parameters Measurement at Rest and Detection of Diagnostic Indices in Sleep Compared to Cardiorespiratory Polygraphy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
January 12, 2022 (Actual)
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
The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. Additionally, the investigators will evaluate Sleepiz One+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. Participants will undergo measurement with Sleepiz One+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
respiration, sleep
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with sleep disorders, cardiorespiratory or neuromuscular disorders
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sleepiz One+
Intervention Description
Simultaneous sleep study with polysomnography and Sleepiz One+
Intervention Type
Device
Intervention Name(s)
Polysomnography
Intervention Description
Simultaneous sleep study with polysomnography and Sleepiz One+
Primary Outcome Measure Information:
Title
Respiration rate measurement accuracy agreement
Time Frame
60 seconds
Secondary Outcome Measure Information:
Title
Binary classification of sleep apnea severity based on the AHI > 15 of Sleepiz One+ compared to results of Domino software and data manually scored by sleep technician
Time Frame
1 Night
Title
Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula
Time Frame
60 seconds
Title
Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt
Time Frame
1 Night
Title
Average respiration rate agreement between Sleepiz One+ and nasal cannula
Time Frame
1 Night
Title
Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician
Time Frame
60 seconds
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
Patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders
Ambulatory or stationary patients of Klinik Lengg
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
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartosz Bujan, Dr. med.
Organizational Affiliation
Klinik Lengg AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik Lengg AG
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of a Contactless Vital Signs Measurement Sensor
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