Evaluation of an MRI-compatible Vital Signs Sensor System (OPTO-MRI)

Clinical Evaluation of a Fiber-optic Sensor System for Monitoring Respiration Activity and Heart Work During MRI Examinations

This study is to determine the possibility of assessing the level of anxiety in MRI patients by means of the respiration rate (RR) and heart rate (HR) indicators acquired by a fiber-optic sensor system. The mean RR and/or HR values recorded at the beginning and the end of an MRI scanning will be referred to the State Trait Anxiety Inventory (STAI) scores completed before and after the MRI scanning, respectively.

Study Overview

• Status: Completed
• Conditions: Stress; Hyperventilation; Anxiety; Claustrophobia
• Intervention / Treatment: Diagnostic test: MRI examination

Detailed Description

The main purpose of the study is to determine the possibility of assessing the level of anxiety by means of the respiration curve and/or ballistocardiographic (BCG) signal acquired from MRI patients using a fiber-optic sensor system. In many patients, the MRI examination causes enormous stress due to limited space in the scanner, isolation during the examination and high noise levels. Usually, anxiety or stress triggers an increase in respiration rate (RR), leading to hyperventilation in extreme cases. There are also frequent cases of disturbances in heart rate (HR). Thus, the symptoms of claustrophobia can be detected by monitoring respiration activity and heart work.

The fiber-optic sensor system consists of a sensor mat, an interrogator and a personal computer (PC), and records respiratory and BCG signals in patients during MRI. The metal-free sensor mat is placed under the patient's back, does not pose a threat to the patient and has no influence over the quality of imaging. The interrogation module detects the optical signal including vital signs, and the PC with software developed for signal processing and visualization enable the MRI operator to monitor patient's RR and HR.

Up to 200 MRI patients in different age, weight, and gender will be participated in the study. They will be asked to complete the State Trait Anxiety Inventory (STAI) questionnaire in order to estimate anxiety level before and after the MRI scanning. Relations between the STAI X-1 scores and the mean RR and/or HR values recorded at the beginning and the end of the MRI scanning will be analyzed using descriptive statistic methods. The research scheme includes also the collection of the STAI X-2 scores before the MRI scanning. Finally, the values of the physiological parameters, which may indicate a dangerous level of anxiety will be determined. Positive results of the clinical evaluation will predestine the fiber-optic sensor system to be implemented in routine MRI procedures.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-755
    • Military Institute of Aviation Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Up to 200 MRI patients of different age, weight and sex.

Description

Inclusion Criteria:

• MRI patients

Exclusion Criteria:

• Same as in MRI procedures

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MRI patients; Up to 200 patients of different age, weight and sex, which undergo MRI examinations.	Diagnostic test: MRI examination; The part of the body that is being scanned and the time of the MRI examination are not relevant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optical signal	Instantaneous spectral position of the fiber Bragg grating (FBG) reflection peak in nanometers that represents respiration curve and ballistocardiogram	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RR	Respiration rate in respirations per minute	60 minutes
HR	Heart rate in beats per minute	60 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
RR_1	Respiration rate at the beginning of the MRI scanning in respirations per minute	2 minutes
RR_2	Respiration rate at the end of the MRI scanning in respirations per minute	2 minutes
HR_1	Heart rate at the beginning of the MRI scanning in beats per minute	2 minutes
HR_2	Heart rate at the end of the MRI scanning in beats per minute	2 minutes
STAI X-1_1	STAI X-1 scores completed before the MRI scanning. Scale range: 20 - 80 (raw scores), where 20 means low anxiety, and 80 indicates high anxiety (the higher the result, the higher the level of anxiety).	1 minute
STAI X-1_2	STAI X-1 scores completed after the MRI scanning. Scale range: 20 - 80 (raw scores), where 20 means low anxiety, and 80 indicates high anxiety (the higher the result, the higher the level of anxiety).	1 minute
STAI X-2	STAI X-2 scores completed before the MRI scanning. Scale range: 20 - 80 (raw scores), where 20 means low anxiety, and 80 indicates high anxiety (the higher the result, the higher the level of anxiety).	1 minute

Collaborators and Investigators

• Sponsor: Military Institute of Aviation Medicine
• Investigators: Principal Investigator: Łukasz Dziuda, DSc, PhD, Military Institute of Aviation Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Physiological parameters; Fiber-optic sensor system; Medical monitoring
• Additional Relevant MeSH Terms: Mental Disorders; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Phobic Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Hyperventilation; Claustrophobia
• Other Study ID Numbers: OPTO-MRI_01/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No