NCT04487899

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

July 22, 2020

Last Update Submit

September 14, 2022

Conditions

Keywords

Emergency missionsAssesmentMilitary Health Servicesheart rate variabilityautonomic nervous system

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (9)

  • Standard Deviation 1 (SD1)

    1 week

  • Standard Deviation 2 (SD2)

    1 week

  • Min_HR

    1 week

  • Max_HR

    1 week

  • Mean_HR

    1 week

  • +4 more secondary outcomes

Study Arms (2)

Instructors group

Group of flight instructors at the reactor school.

Device: Analysis of heart rate variability

Students group

Group of students at the reactor school.

Device: Analysis of heart rate variability

Interventions

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).

Instructors groupStudents group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The selection of the sample was made in the accessible population of the Talavera la Real Air Base (Badajoz).

You may qualify if:

  • 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).

You may not qualify if:

  • Any uncontrolled neurological or cardiac disorder.
  • Being involved in ongoing medical-legal conflicts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Extremadura

Badajoz, 06006, Spain

Location

Related Publications (7)

  • 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.

    PMID: 26792776BACKGROUND
  • 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.

    PMID: 24610637BACKGROUND
  • 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.

    PMID: 12955518BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 25364865BACKGROUND
  • Fernandez-Morales C, Espejo-Antunez L, Clemente-Suarez VJ, Tabla-Hinojosa FB, Albornoz-Cabello M. Analysis of heart rate variability during emergency flight simulator missions in fighter pilots. BMJ Mil Health. 2024 Jul 24;170(4):296-302. doi: 10.1136/military-2022-002242.

Study Officials

  • Luis Espejo-Antúnez, PhD

    Universidad de Extremadura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 27, 2020

Study Start

October 1, 2019

Primary Completion

November 18, 2019

Study Completion

March 10, 2020

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations