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Non-contact Sleep Apnea Identification in Neurological Rehabilitation

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ClinicalTrials.gov Identifier: NCT04803552
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Sleepiz AG

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sleep Apnea Stroke Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Identification of Patients With Clinically Relevant Sleep Apnea With a Contactless Device in Rehabilitation Clinic
Actual Study Start Date : April 15, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Contactless sleep apnea screening vs respiratory polygraphy 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04803552


Contacts
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Contact: Jens Acker, Dr. +41 56 269 60 20 j.acker@ksm.ch

Locations
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Switzerland
KSM Bad Zurzach Recruiting
Bad Zurzach, Aargau, Switzerland, 5330
Contact: Jens Acker       jens.acker@zurzachcare.ch   
Sponsors and Collaborators
Sleepiz AG
Investigators
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Principal Investigator: Jens Acker, Dr. KSM Bad Zurzach
More Information
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Responsible Party: Sleepiz AG
ClinicalTrials.gov Identifier: NCT04803552    
Other Study ID Numbers: 20-025-EX-KSM Bad Zurzach
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sleepiz AG:
stroke
sleep apnea
contactless
screening
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders