- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04487899
Analysis of Heart Rate Variability During Emergency Flight Simulator Missions in Fighter Pilots
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The autonomous response of fighter and attack pilots during emergency situations in a flight simulator will be assessed by measuring and analysing heart rate variability (HRV). Eighteen pilots with instructor or student status assigned at the time of the evaluation to the ALA 23 district of the Talavera la Real Air Base of the Ministry of Defence of the Spanish Government (Badajoz) were studied during emergency situations in flight simulator. Subjects were assigned by non-probabilistic randomisation to an instructor group (IG; 7 subjects), and to a student group (AG; 11 subjects).
The recording of the parameters indicated corresponds to the emergency situations described above. Data collection was made in three different moments:
- Take-off: it starts after reading the checklist until the engine fault is resolved.
- Flight: during manoeuvres characterised by the recovery of abnormal positions.
- Landing: where the pilot performs the landing manoeuvre, with the loss of spatial situation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Badajoz, Spain, 06006
- Universidad de Extremadura
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pilots who had the status of instructor or student assigned at the time of assessment to the ALA 23 district of the Talavera la Real Air Base of the Ministry of Defense of the Government of Spain (Badajoz).
Exclusion Criteria:
- Any uncontrolled neurological or cardiac disorder.
- Being involved in ongoing medical-legal conflicts.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Instructors group
Group of flight instructors at the reactor school.
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The HR HRV interval of the heartbeat (variations in the time interval between beats) was used as a measure of autonomous modulation, and the Firstbeat Bodyguard monitor (Firstbeat Technologies, Jyväskylä, Finland) was used to record HRV data during the session with emergency situations in the flight simulator.
Data was downloaded from the devices to a computer using Firstbeat Uploader software (Firstbeat Technologies), and all R-R interval series were imported into the Kubios software package (University of Eastern Finland, Kuopio, Finland).
To calculate the autonomous equilibrium, the commonly used HRV method based on the Poincaré graph was used (Brennan et al., 2001; Mourot et al., 2004).
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Students group
Group of students at the reactor school.
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The HR HRV interval of the heartbeat (variations in the time interval between beats) was used as a measure of autonomous modulation, and the Firstbeat Bodyguard monitor (Firstbeat Technologies, Jyväskylä, Finland) was used to record HRV data during the session with emergency situations in the flight simulator.
Data was downloaded from the devices to a computer using Firstbeat Uploader software (Firstbeat Technologies), and all R-R interval series were imported into the Kubios software package (University of Eastern Finland, Kuopio, Finland).
To calculate the autonomous equilibrium, the commonly used HRV method based on the Poincaré graph was used (Brennan et al., 2001; Mourot et al., 2004).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Root Mean Square of the Successive Differences (RMSSD)
Time Frame: 1 week
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It indicates the degree of activation of the Parasympathetic Nervous System on the cardiovascular system.
It is obtained from the square root of the mean value of the sum of the squared differences of all successive RR intervals.
This parameter reports the short-term variations of the RR intervals.
It is directly associated with short-term variability.
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1 week
|
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Stress Score
Time Frame: 1 week
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It is an index described by Naranjo-Orellana et al. to facilitate physiological interpretation of Poincaré plot.
It is expressed as the inverse of the SD2 diameter multiplied by 1000 and is considered directly proportional to the sympathetic activity in the sinus node.
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1 week
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Sympathetic/parasympathetic ratio (S/PS)
Time Frame: 1 week
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It is also described by Naranjo-Orellana et al., S/PS is expressed as the quotient of SS and SD1, and it is considered to reflect autonomic balance - that is, the relationship between sympathetic and parasympathetic activity
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1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Standard Deviation 1 (SD1)
Time Frame: 1 week
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It indicates the sensitivity of short-term variability in HRV non-linear spectrum.
It is considered an indicator of parasympathetic activity.
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1 week
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Standard Deviation 2 (SD2)
Time Frame: 1 week
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It is a diameter from Poincaré plot which indicates the degree of longitudinal dispersion.
It is thought to reflect long-term changes in RR intervals and it is considered an inverse indicator of parasympathetic activity.
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1 week
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Min_HR
Time Frame: 1 week
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Minimum heart rate variability.
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1 week
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Max_HR
Time Frame: 1 week
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Maximum heart rate variability.
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1 week
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Mean_HR
Time Frame: 1 week
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It corresponds to the interval between two beats (R peaks on the ECG).
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1 week
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pNN50
Time Frame: 1 week
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Percentage of consecutive RR intervals that differ by more than 50 ms from each other.
A high value of pNN50 provides valuable information about high spontaneous HR.
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1 week
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Low Frequency Power (LF)
Time Frame: 1 week
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Situated between 0.04 and 0.15 Hz.
In long-term recordings it provides us with more information about the activity of the SNS.
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1 week
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High Frequency Power (HF)
Time Frame: 1 week
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They are located between 0.15 and 0.4 Hz.
HF is clearly related to PNS activity and has a relaxation-related effect on HR2.
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1 week
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Low/High Frequency ratio (HF/LF)
Time Frame: 1 week
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From low frequency and high frequency ratio of the HRV spectral analysis result we can estimate the vagal (related to relaxation and HF) and sympathetic (related to stress and LF) influence.
Thus we can estimate sympathetic-vagal balance.
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1 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luis Espejo-Antúnez, PhD, Universidad de Extremadura
Publications and helpful links
General Publications
- de la Cruz Torres B, Albornoz Cabello M, Garcia Bermejo P, Naranjo Orellana J. Autonomic responses to ultrasound-guided percutaneous needle electrolysis of the patellar tendon in healthy male footballers. Acupunct Med. 2016 Aug;34(4):275-9. doi: 10.1136/acupmed-2015-010993. Epub 2016 Jan 20.
- Kitagawa Y, Kimura K, Yoshida S. Spectral analysis of heart rate variability during trigger point acupuncture. Acupunct Med. 2014 Jun;32(3):273-8. doi: 10.1136/acupmed-2013-010440. Epub 2014 Mar 7.
- Mourot L, Bouhaddi M, Perrey S, Rouillon JD, Regnard J. Quantitative Poincare plot analysis of heart rate variability: effect of endurance training. Eur J Appl Physiol. 2004 Jan;91(1):79-87. doi: 10.1007/s00421-003-0917-0. Epub 2003 Sep 4.
- Gil-Rodas F, Pedret C, Ramos-Castro J, Capdevila-Ortís L. Variabilidad de la frecuencia cardíaca: concepto, medidas y relación con aspectos clínicos (I). Arch Med Deporte Rev Fed Esp Med Deporte Confed Iberoam Med Deporte. 2008;(123):41-8.
- Malik M. Heart rate variability: Standards of measurement, physiological interpretation, and clinical use: Task force of the European Society of Cardiology and the North American Society for Pacing and Electrophysiology. Ann Noninvasive Electrocardiol. 1996;1(2):151-81.
- Naranjo Orellana J, de la Cruz Torres B, Sarabia Cachadina E, de Hoyo M, Dominguez Cobo S. Two new indexes for the assessment of autonomic balance in elite soccer players. Int J Sports Physiol Perform. 2015 May;10(4):452-7. doi: 10.1123/ijspp.2014-0235. Epub 2014 Oct 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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