The Affect of a Ventilated Helmet on Physiological Load

NCT ID: NCT01595906

Last Updated: 2012-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-02-28

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.

Detailed 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).

Conditions

Physiological Strain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The experiment subjects

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.

Group Type: EXPERIMENTAL

Ventilated Helmet

Intervention Type: 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.

Interventions

Ventilated Helmet

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Corps, Israel Defense Force

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Druyan, M.D

Role: PRINCIPAL_INVESTIGATOR

IDF medical corps

Locations

Heller insitute, Sheba hospital

Ramat Gan, , Israel

Countries

Israel

Central Contacts

Amit Druyan, M.D

Role: CONTACT

Amit.Druyan@sheba.health.gov.il

Facility Contacts

Amit Druyan, M.D

Role: primary

Amit.Druyan@sheba.health.gov.il

Other Identifiers

1037-2011-IDF-CTIL

Identifier Type: -

Identifier Source: org_study_id