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Heart Rate VariabilityNCT04487899

Analysis of Heart Rate Variability During Emergency Flight Simulator Missions in Fighter Pilots

An observational study of Heart Rate Variability and Autonomic Nervous System, run by Universidad de Extremadura at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Any age
What is being tested?
Analysis of heart rate variability
Type of treatment
Medical device
How many people
18 participants
Where
1 siteSpain
Study dates
1 Oct 2019to 10 Mar 2020
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: The selection of the sample was made in the accessible population of the Talavera la Real Air Base (Badajoz).

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad de Extremadura

    Badajoz, 06006

Other trials in Spain

About this study

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).

Read the 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:

  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.
Being tested
Analysis of heart rate variability
Keywords
Emergency missions, Assesment, Military Health Services, heart rate variability, autonomic nervous system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Analysis of heart rate variabilityDevice

    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).

Study groups in NCT04487899
Study groupRoleWhat they receive
Instructors groupGroup of flight instructors at the reactor school.
Receives: Device: Analysis of heart rate variability
Students groupGroup of students at the reactor school.
Receives: Device: Analysis of heart rate variability

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 week

  2. 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.

    Measured: 1 week

  3. 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

    Measured: 1 week

Secondary outcomes (9)

  1. 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.

    Measured: 1 week

  2. 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.

    Measured: 1 week

  3. Min_HR

    Minimum heart rate variability.

    Measured: 1 week

  4. Max_HR

    Maximum heart rate variability.

    Measured: 1 week

  5. Mean_HR

    It corresponds to the interval between two beats (R peaks on the ECG).

    Measured: 1 week

  6. 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.

    Measured: 1 week

  7. 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.

    Measured: 1 week

  8. 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.

    Measured: 1 week

  9. 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.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start1 Oct 2019
  3. Primary completion18 Nov 2019
  4. Study completion10 Mar 2020

Resources

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
Cross-sectional
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04487899
Sponsor's protocol ID
02
Status last verified
Sep 2022
First submitted
22 Jul 2020
Last updated
16 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26792776

  • 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.

    PubMed 24610637

  • 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.

    PubMed 12955518

  • 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.

    PubMed 25364865

  • 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.

    PubMed 36585028

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Rate Variability and Autonomic Nervous System, run by Universidad de Extremadura at 1 site in Spain.

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 2 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 16 Sep 2022. 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 Spain. 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?

Root Mean Square of the Successive Differences (RMSSD) (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04487899, which also lists 7 linked publications.

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 16 Sep 2022.

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