The Affect of a Ventilated Helmet on Physiological Load

NCT01595906 | Unknown

• 1 other identifier: 1037-2011-IDF-CTIL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The use of infantry helmets under heavy heat stress conditions, during physical exertion, may hinder the body's ability to effectively dissipate heat from the head area, thereby damaging the soldier's function. Therefore head cooling may potentially enable a longer duration of activity until reaching fatigue. An improvement in function may also be possible.The purpose of this research is to determine the extent of the cognitive and physiological strain caused by wearing a helmet under exertional conditions while exposed to heavy heat stress and to evaluate the effect of a unique ventilation system connected to the helmet on strain reduction.

Conditions

Physiological Strain

Keywords

Helmet; Heat Tolerance Test; ventilation System

Outcome Measures

Primary Outcomes (1)

• Physiological strain

  The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test(HTT).

  9 days

Secondary Outcomes (4)

• Rectal temperature

  9 days

• Skin temperature

  9 days

• Heart Rate

  9 days

• Sweat Rate

  9 days

Study Arms (1)

The experiment subjects

EXPERIMENTAL

The subjects will undergo: 1. 6 acclimatization days carried out by a standard protocol including a daily 2 hour effort performed in a climatic chamber, during which the subjects walk on a treadmill at 5km/h on a 2% incline under heat conditions (40 deg. centigrade \& 40% RH). Core (rectal) and skin temperatures and heart rate will be monitored continuously. 2. Three consecutive days including 3 scenarios: 1. Without a helmet b.With a helmet c.With a ventilated helmet During the experiment days the subjects will be exposed to the following protocol : A 5 minute sitting, performing cognitive tests on a computer for 15 min, 120 min walking on a treadmill at 5km/h on a 2% incline, at the end of the effort the same cognitive tests will be repeated for extra 15 min, 155 min in total.

Procedure: Ventilated Helmet

Interventions

Ventilated Helmet PROCEDURE

The ventilation system is installed on the inner part of the helmet and connected to a bellows and an energy source placed on the vest worn by the soldier. The system's working principal is based on air perfusion with a small ventilator.

The experiment subjects

Eligibility Criteria

• Age: 21 Years - 28 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy civilian volunteers
• aged 21-28
• without known medical illnesses or medication use

You may not qualify if:

• the existence of or suspicion of existing cardiac or respiratory disease
• hypertension
• diabetes
• any hormonal disease or any other chronic illness that may inhibit participation in the experiment
• infectious disease 3 days prior to the experiment.

Sponsors & Collaborators

• Medical Corps, Israel Defense Force: lead

Study Sites (1)

Heller insitute, Sheba hospital

Ramat Gan, Israel

Location

Study Officials

• Amit Druyan, M.D

  IDF medical corps

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Druyan, M.D

CONTACT

Amit.Druyan@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: May 10, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

IL (1)