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The Affect of a Ventilated Helmet on Physiological Load

M

Medical Corps, Israel Defense Force

Status

Unknown

Conditions

Physiological Strain

Treatments

Procedure: Ventilated Helmet

Study type

Interventional

Funder types

Other

Identifiers

NCT01595906
1037-2011-IDF-CTIL

Details and patient eligibility

About

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.

Full description

12 young, healthy civilian volunteers, aged 21-28 will participate in the study. Following a day of examinations and 6 days of acclimatization in a climatic chamber in accordance with a well accepted protocol, the subjects will undergo 3 days of experiment that will include exposure to hot environmental conditions with different helmet-wearing scenarios, while wearing uniform and a combat vest: (a) without a helmet (b) with a helmet (c) with a helmet connected to a ventilation system. All 3 scenarios will include a two hour effort (walking on a treadmill) in heavy heat stress in the climatic chamber at our institute (the Heller institute of medical research).

Enrollment

12 estimated patients

Sex

Male

Ages

21 to 28 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

The experiment subjects
Experimental group
Description:
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.
Treatment:
Procedure: Ventilated Helmet

Trial contacts and locations

1

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Central trial contact

Amit Druyan, M.D

Data sourced from clinicaltrials.gov

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