Non-contact Sleep Apnea Identification in Neurological Rehabilitation

NCT04803552 | Unknown

• 1 other identifier: 20-025-EX-KSM Bad Zurzach
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Stroke

Keywords

stroke; sleep apnea; contactless; screening

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Contactless sleep apnea screening vs respiratory polygraphy

EXPERIMENTAL

Device: Overnight sleep study with Sleepiz One and a respiratory polygraphy

Interventions

Overnight sleep study with Sleepiz One and a respiratory polygraphy DEVICE

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

Contactless sleep apnea screening vs respiratory polygraphy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18years
• Ability and consent to undergo electrophysiological routine assessment
• Informed Consent as documented by signature
• In-patients of RehaClinic Bad Zurzach

You may not qualify if:

• 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

Sponsors & Collaborators

• Sleepiz AG: lead

Study Sites (1)

KSM Bad Zurzach

Bad Zurzach, Canton of Aargau, 5330, Switzerland

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Stroke

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jens Acker, Dr.

  KSM Bad Zurzach

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Acker, Dr.

CONTACT

+41 56 269 60 20; j.acker@ksm.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 17, 2021
• Study Start: April 15, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)