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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04487899
Other study ID # 02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date March 10, 2020

Study information

Verified date September 2022
Source Universidad de Extremadura
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The autonomous response of fighter and attack pilots who attend sessions in a flight simulator will be evaluated by measuring and analyzing heart rate variability (HRV).


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: 1. Take-off: it starts after reading the checklist until the engine fault is resolved. 2. Flight: during manoeuvres characterised by the recovery of abnormal positions. 3. Landing: where the pilot performs the landing manoeuvre, with the loss of spatial situation.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date March 10, 2020
Est. primary completion date November 18, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Device:
Analysis of heart rate variability
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).

Locations

Country Name City State
Spain Universidad de Extremadura Badajoz

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Extremadura

Country where clinical trial is conducted

Spain, 

References & Publications (6)

de la Cruz Torres B, Albornoz Cabello M, García 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. — View Citation

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.

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. — View Citation

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.

Mourot L, Bouhaddi M, Perrey S, Rouillon JD, Regnard J. Quantitative Poincaré plot analysis of heart rate variability: effect of endurance training. Eur J Appl Physiol. 2004 Jan;91(1):79-87. Epub 2003 Sep 4. — View Citation

Naranjo Orellana J, de la Cruz Torres B, Sarabia Cachadiña E, de Hoyo M, Domínguez 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Root Mean Square of the Successive Differences (RMSSD) 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. 1 week
Primary Stress Score 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. 1 week
Primary Sympathetic/parasympathetic ratio (S/PS) 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 1 week
Secondary Standard Deviation 1 (SD1) It indicates the sensitivity of short-term variability in HRV non-linear spectrum. It is considered an indicator of parasympathetic activity. 1 week
Secondary Standard Deviation 2 (SD2) 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. 1 week
Secondary Min_HR Minimum heart rate variability. 1 week
Secondary Max_HR Maximum heart rate variability. 1 week
Secondary Mean_HR It corresponds to the interval between two beats (R peaks on the ECG). 1 week
Secondary pNN50 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. 1 week
Secondary Low Frequency Power (LF) Situated between 0.04 and 0.15 Hz. In long-term recordings it provides us with more information about the activity of the SNS. 1 week
Secondary High Frequency Power (HF) 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. 1 week
Secondary Low/High Frequency ratio (HF/LF) 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. 1 week
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