Wearable Sensors for Delirium Detection at an Early Stage (WeSen_delirium)

NCT05677646 | Recruiting

• 1 other identifier: 01
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

Delirium is an acute brain-organic syndrome: its clinical manifestation and form are results of a highly complex pathophysiology. Delirium is a serious clinical problem in hospitalized adults. It is the most common neuropsychiatric complication of hospitalization and is associated with high patient burden, increased morbidity and mortality, prolonged length of stay, higher costs, and institutionalization. An early, accurate diagnosis as well as an adequate management are critical to the continued health and functional independence of the affected patients. Prevention strategies contain pharmacological and non-pharmacological interventions. However, their clinical success (effectiveness) is limited and the evidence for the use of pharmacological interventions for the prevention or management of delirium is scarce. The prediction of delirium has become a new promising topic in clinical research. New approaches like the implementation of wearable sensors, in particular wearable accelerometer devices to record movements related to delirium are promising. In this study, the study procedure only includes wearing a consumer-grade sensor on the wrist of the not-dominant hand. This way, vital parameters are measured in order to identify patterns.

Conditions

Delirium

Keywords

delirium; physical activity; sleep; activity sensor; early detection

Outcome Measures

Primary Outcomes (9)

• total sleep time

  measured daily over the course of the study, from enrolment to the end of the study, on average 1 week

• time spend in different sleep stages (deep, light, REM, awake)

  measured daily over the course of the study, from enrolment to the end of the study, on average 1 week

• heart rate

  measured continuously over the course of the study, from enrolment to the end of the study, on average 1 week

• resting heart rate

  measured daily over the course of the study, from enrolment to the end of the study, on average 1 week

• heart rate variability

  measured daily over the course of the study, from enrolment to the end of the study, on average 1 week

• oxygen saturation

  measured daily over the course of the study, from enrolment to the end of the study, on average 1 week

• breathing rate

  measured daily over the course of the study, from enrolment to the end of the study, on average 1 week

• skin temperature variation

  measured daily over the course of the study, from enrolment to the end of the study, on average 1 week

• Delirium Observation Scale (DOS)

  measured three times per day over the course of the study, from enrolment to the end of the study, on average 1 week

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female inpatients at the Department of Internal Medicine of the University Hospital Zurich and at the Institute of General Internal Medicine Klinik Hirslanden Zurich, respectively, 65 years or older and without acute delirium or previous diagnosis of it one month prior to admission are eligible for the study. Patients interested in the study will be provided with the study information sheet, detailing study aims and procedure. Patients will be enrolled if they agree to participate and provide written informed consent.

You may qualify if:

• Female and male inpatients aged 65 years or older
• Cognitive ability to understand, consent to and participate in the study
• Fluent in German
• Provision of written informed consent

You may not qualify if:

• The presence of acute delirium,
• or a delirium diagnosis made within the last 4 weeks prior to hospitalization,
• The likelihood of an alcohol withdrawal delirium (CAGE Score \>1)
• Limited knowledge of the German language
• Dementia (Mini Mental Status Test Score ≤24)

Sponsors & Collaborators

• University of Zurich: lead
• Klinik Hirslanden, Zurich: collaborator

Study Sites (2)

Klinik Hirslanden

Zurich, Switzerland

RECRUITING

University Hospital Zurich, Internal Medicine

Zurich, Switzerland

RECRUITING

Related Publications (10)

• Davoudi A, Manini TM, Bihorac A, Rashidi P. Role of Wearable Accelerometer Devices in Delirium Studies: A Systematic Review. Crit Care Explor. 2019 Sep 13;1(9):e0027. doi: 10.1097/CCE.0000000000000027. eCollection 2019 Sep.

  PMID: 32166280 BACKGROUND

• Godfrey A, Conway R, Leonard M, Meagher D, Olaighin GM. Motion analysis in delirium: a discrete approach in determining physical activity for the purpose of delirium motoric subtyping. Med Eng Phys. 2010 Mar;32(2):101-10. doi: 10.1016/j.medengphy.2009.10.012. Epub 2009 Nov 26.

  PMID: 19931480 BACKGROUND

• Godfrey A, Leonard M, Donnelly S, Conroy M, Olaighin G, Meagher D. Validating a new clinical subtyping scheme for delirium with electronic motion analysis. Psychiatry Res. 2010 Jun 30;178(1):186-90. doi: 10.1016/j.psychres.2009.04.010. Epub 2010 May 10.

  PMID: 20452050 BACKGROUND

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

• Marcantonio ER. Delirium in Hospitalized Older Adults. N Engl J Med. 2018 Jan 4;378(1):96-97. doi: 10.1056/NEJMc1714932. No abstract available.

  PMID: 29298149 BACKGROUND

• Scheffer AC, van Munster BC, Schuurmans MJ, de Rooij SE. Assessing severity of delirium by the Delirium Observation Screening Scale. Int J Geriatr Psychiatry. 2011 Mar;26(3):284-91. doi: 10.1002/gps.2526.

  PMID: 20665557 BACKGROUND

• Schuurmans MJ, Shortridge-Baggett LM, Duursma SA. The Delirium Observation Screening Scale: a screening instrument for delirium. Res Theory Nurs Pract. 2003 Spring;17(1):31-50. doi: 10.1891/rtnp.17.1.31.53169.

  PMID: 12751884 BACKGROUND

• van Uitert M, de Jonghe A, de Gijsel S, van Someren EJ, de Rooij SE, van Munster BC. Rest-activity patterns in patients with delirium. Rejuvenation Res. 2011 Oct;14(5):483-90. doi: 10.1089/rej.2011.1181. Epub 2011 Sep 28.

  PMID: 21954983 BACKGROUND

• Vasilevskis EE, Han JH, Hughes CG, Ely EW. Epidemiology and risk factors for delirium across hospital settings. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):277-87. doi: 10.1016/j.bpa.2012.07.003.

  PMID: 23040281 BACKGROUND

• Zipser CM, Knoepfel S, Hayoz P, Schubert M, Ernst J, von Kanel R, Boettger S. Clinical management of delirium: The response depends on the subtypes. An observational cohort study in 602 patients. Palliat Support Care. 2020 Feb;18(1):4-11. doi: 10.1017/S1478951519000609.

  PMID: 31506133 BACKGROUND

MeSH Terms

Conditions

Delirium; Motor Activity

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Martina Kleber, PD Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Viktor von Wyl, Prof. Dr.

  University of Zurich

  STUDY DIRECTOR

• Rahel Naef, Prof. Dr.

  University of Zurich

  STUDY DIRECTOR

Central Study Contacts

Martina Kleber, PD Dr.

CONTACT

+41 44 387 20 60; Martina.Kleber@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: January 10, 2023
• Study Start: November 23, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)