Effects of Voluntary Neck Extension on Cerebral Blood Flow, in Breath-hold Divers Ending an Apnoea of Two Minutes or More. (APNECK)

August 14, 2017 updated by: Nantes University Hospital

Effect of Voluntary Neck Extension in the Occurrence of an Increase in the Pulsatility Index of Right Internal Carotid Artery in the Amateur Diver, Performing an Apnoea of Two Minutes or More: a Prospective, Monocentric, Open Interventional Study

The aim of this study is to demonstrate the effect of the voluntary neck extension in the occurrence of an increase in the pulsatility index of the right internal carotid artery in the amateur diver, realizing an apnea of two minutes or more.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

In literature concerning apnoea, accidents have been described during neck extension.

Accidental drowning are frequent on the French coast every year and many of them concern apneists victims of apnoeic blackout.

Neck extension is thus suspected to possibly produce an apnoeic blackout at the end of the dive since 1965, when Sir Sciarli (diving medicine pioneer) suspected this hypothesis.

Physiologically, during a dive in apnea, the human cardiovascular system is subjected to a parasympathetic dominance, via the apnea reflex and the diving reflex. This parasympathetic dominant could be reinforced during a neck extension at the end of snorkeling during the ascent.

Hypothesis: the neck extension at the end of apnea contributes to increase the pulsatility index of the right internal carotid artery by vagal component and thus causes a decrease in cerebral blood flow and may lead to the initiation of syncope in the healthy amateur free diver or underwater fisherman.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nantes, France, 44093
        • Nantes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 51 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Major (≥18 years), under the age of 51
  • Male
  • Can hold an apnea of 2 minutes or more
  • Practicing for less than 2 years the apnea at the rate of at least 10 sessions of apnea in the year
  • Not having a known cardiovascular history : any form of heart rhythm disorder, Ischemic heart disease, angina, arteriopathy, any valvular pathology, high blood pressure ...
  • No known respiratory history (asthma, Chronic Obstructive Pulmonary Disease, bronchiectasis, pulmonary emphysema, pneumothorax, pleurisy, pulmonary infection, lobectomy ...)
  • No neurological history of type: epilepsy, deficit syndrome, iterative loss of knowledge, recent head trauma with loss of consciousness

Exclusion Criteria:

  • - Minors and persons over 51 years of age
  • Person under curators or trusteeship
  • Person with a history of cardiovascular, respiratory or epilepsy as cited by the French Federation of Study and Submarine Sports, which poses as a contra-indication to the practice of apnea: Cardiac insufficiency, Obstructive Cardiomyopathy, syncopal risk pathology (valvulopathies type aorting narrowing or mitral narrowing), paroxysmal tachycardia, non-paired auriculo ventricular block 2/3, stroke, uncontrolled hypertension after stress test, recent infarction, angina, pericarditis. Asthma stage 3, severe Chronic Obstructive Pulmonary Disease, bronchiectasis, pulmonary emphysema, pneumothorax, pleurisy, pulmonary infection, lobectomy ...) Epilepsy, deficit syndrome, iterative loss of knowledge, recent head trauma with loss of consciousness in difficulty, symptomatic cervical or lumbar disc herniation
  • Patient with medical treatment affecting the cardiovascular or respiratory system (for example: ventolin, betablocker ...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: apnea performing

The included subjects will make an apnea of two minutes or more, sitting on a chair with cold strips on the face, initially with the head in neutral position. Then, when they feel the end of their apnea, they will have to raise their left hand to signal it to the Doppler manipulator, who will then realize the apnea reference measurement.

As soon as this is done, the subjects will be asked to perform an extension of the neck, so as to look at the ceiling. A final measurement will then be made in apnea, the head always in extension. Subjects then resume their breathing in this same position. A final measurement will then be made.

The included subjects will make an apnea of two minutes or more, sitting on a chair with cold strips on the face, initially with the head in neutral position. Then, when they feel the end of their apnea, they will have to raise their left hand to signal it to the Doppler manipulator, who will then realize the apnea reference measurement.

As soon as this is done, the subjects will be asked to perform an extension of the neck, so as to look at the ceiling. A final measurement will then be made in apnea, the head always in extension. Subjects then resume their breathing in this same position. A final measurement will then be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of the voluntary neck extension in the occurrence of an increase in the pulsatility index of the right internal carotid artery in the amateur diver, realizing an apnea of two minutes or more
Time Frame: 2 minutes or more: at the breaking point of apnea.
To demonstrate the potential implication of cervical extension in the decrease of cerebral blood flow in amateur diver apnea by measuring the variation in the pulsatility index of the right internal carotid artery (RICAPI), by the intra-individual comparison of the RICAPI in amateur diver in rupture of apnea with neck extension (NE) versus the RICAPI of amateur diver in rupture of apnea without NE.
2 minutes or more: at the breaking point of apnea.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Antoine ANDRE, Doctor, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

July 24, 2017

Study Completion (Actual)

July 24, 2017

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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