Heart Rate Variability Clinical Trial
Official title:
Analysis of Heart Rate Variability During Emergency Flight Simulator Missions in Fighter Pilots
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 |
Verified date | September 2022 |
Source | Universidad de Extremadura |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de Extremadura | Badajoz |
Lead Sponsor | Collaborator |
---|---|
Universidad de Extremadura |
Spain,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Recruiting |
NCT04554160 -
Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
|
||
Completed |
NCT02153385 -
Effects of Yoga on Heart Rate Variability and Mood in Women
|
N/A | |
Terminated |
NCT04381182 -
Heart Rate Variability and Stress Management Enhancement
|
N/A | |
Active, not recruiting |
NCT04342078 -
Vitamin D and Health Outcomes in Preterm Born Population
|
||
Completed |
NCT03068182 -
Effects of Arm Crank Versus Treadmill Exercises on Heart Rate Variability in Adult Subjects.
|
N/A | |
Recruiting |
NCT06101225 -
Effects of a Relaxation and Guided Imagery Intervention in School Context
|
N/A | |
Recruiting |
NCT05679882 -
Effects of Natural Sounds on Attention Restoration Outdoors
|
N/A | |
Recruiting |
NCT05950698 -
Obesity and Bariatric Surgery According to a Biopsychosocial Perspective.
|
||
Completed |
NCT05093439 -
Heart Rate Variability at the Emergency Department
|
||
Recruiting |
NCT05560893 -
The Heart of the Community Study
|
N/A | |
Completed |
NCT04869176 -
Effect of Caffeine on Heart Rate Variability in Newborns
|
N/A | |
Recruiting |
NCT06425939 -
Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Exercise Performance
|
N/A | |
Recruiting |
NCT05869721 -
Effects of Yoga on Women With Breast Cancer
|
N/A | |
Recruiting |
NCT06450483 -
Compare the Effects of Different AVNS Parameters on Neck Pain, HRV, Balance in Collegiate Atheletes
|
N/A | |
Completed |
NCT02137057 -
The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients
|
N/A | |
Completed |
NCT01908920 -
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
|
N/A | |
Not yet recruiting |
NCT05296616 -
Sleep Quality, Stress Level and Heart Rate Variability of University Students
|
N/A | |
Recruiting |
NCT04826601 -
The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy
|
N/A | |
Not yet recruiting |
NCT06288828 -
The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients With Compensated Cirrhosis
|
N/A |