AnxietyOPTO-MRINCT03384849
Evaluation of an MRI-compatible Vital Signs Sensor System
An observational study of Anxiety and Claustrophobia, run by Military Institute of Aviation Medicine at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anxiety, Claustrophobia, Hyperventilation
- What is being tested?
- MRI examination
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jan 2017to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 200 MRI patients of different age, weight and sex.
Who may be able to join
- MRI patients
Who cannot join
- Same as in MRI procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Claustrophobia, Hyperventilation, Stress
- Being tested
- MRI examination
- Keywords
- Fiber-optic sensor system, Magnetic resonance imaging, Medical monitoring, Physiological parameters
- Medical subject headings
- Anxiety Disorders, Claustrophobia, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examinationDiagnostic test
The part of the body that is being scanned and the time of the MRI examination are not relevant.
| Study group | Role | What they receive |
|---|---|---|
| MRI patients | Up to 200 patients of different age, weight and sex, which undergo MRI examinations. Receives: Diagnostic Test: MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical signal
Instantaneous spectral position of the fiber Bragg grating (FBG) reflection peak in nanometers that represents respiration curve and ballistocardiogram
Measured: 60 minutes
Secondary outcomes (2)
RR
Respiration rate in respirations per minute
Measured: 60 minutes
HR
Heart rate in beats per minute
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start3 Jan 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Institute of Aviation Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Łukasz Dziuda, DSc, PhD, Principal investigator, Military Institute of Aviation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384849
- Sponsor's protocol ID
- OPTO-MRI_01/2017
- Acronym
- OPTO-MRI
- Status last verified
- Mar 2026
- First submitted
- 20 Dec 2017
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Fiber-optic Sensor System for Monitoring Respiration Activity and Heart Work During MRI Examinations
- ClinicalTrials.gov ID
- NCT03384849
- Acronym / sponsor ID
- OPTO-MRI / OPTO-MRI_01/2017
- Conditions
- Anxiety, Claustrophobia, Hyperventilation, Stress
- Keywords
- Fiber-optic sensor system, Magnetic resonance imaging, Medical monitoring, Physiological parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Military Institute of Aviation MedicineOther government
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI patients | – | Diagnostic Test: MRI examinationUp to 200 patients of different age, weight and sex, which undergo MRI examinations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 200 MRI patients of different age, weight and sex.
Key inclusion criteria (1 listed)
- MRI patients
Key exclusion criteria (1 listed)
- Same as in MRI procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI examinationThe part of the body that is being scanned and the time of the MRI examination are not relevant. | Diagnostic test | MRI patients |
Primary outcome
Optical signal
Time frame: 60 minutes
Instantaneous spectral position of the fiber Bragg grating (FBG) reflection peak in nanometers that represents respiration curve and ballistocardiogram
2 secondary outcomes
RR
Time frame: 60 minutes
HR
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Łukasz Dziuda, DSc, PhD principal investigator
Military Institute of Aviation Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Claustrophobia, run by Military Institute of Aviation Medicine at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical signal (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.