ClinicalTrials.gg
CompletedNCT06992050Updated May 28, 2025

Comparative Evaluation of the Thermal Protection Provided by Submarine Rescue Suits: Half Suit Versus Full Suit

An observational study in Cold Exposure, Hypothermia, Thermal Insulation, Immersion Suits, Submarine Evacuation, sponsored by Medical Corps, Israel Defense Force. Completed at 1 site in Israel. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Medical Corps, Israel Defense Force · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 35 Years
Sex
Male
01

Study summary

This study evaluated the thermal and functional performance of full-body versus half-body Submarine Escape Immersion Equipment (SEIE) suits during cold water immersion (\~16.5°C) and raft sitting. Twenty submariners were divided into two groups.

Read the detailed description

This study investigates the performance of full-body versus half-body Submarine Escape Immersion Equipment (SEIE) suits under conditions simulating submarine emergencies in cold water (\~16.5°C). In such scenarios, rapid evacuation and prolonged exposure to cold water pose significant risks of hypothermia and impaired physical function. The aim was to assess and compare the thermal insulation and motor performance effects of both suit designs during water immersion and raft sitting.

Twenty healthy active-duty submariners (age 22 ± 1 years) participated, divided evenly into two groups (full suit vs. half suit). Core temperature was monitored using ingestible sensors, and subjective cold sensation was assessed regularly throughout immersion and raft sitting. Additional outcome measures included fine motor dexterity (assembling shackles) and handgrip strength, recorded before and after exposure.

The experimental protocol involved one session per participant. Anthropometric data were collected, and subjects underwent a controlled immersion and raft sitting protocol using calibrated thermal equipment. Motor function tasks were standardized and repeated to control for learning effects. Statistical analysis included non-parametric repeated measures tests with appropriate corrections for multiple comparisons.

02

Conditions studied

  • Cold Exposure, Hypothermia, Thermal Insulation, Immersion Suits, Submarine Evacuation

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03

In context

Hypothermia

449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

This study's enrollment of 20 is below the median of 95 across 106 observational studies indexed under Hypothermia.

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Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population consists of healthy, active-duty male submariners from the Israeli Navy, aged 20 to 25 years. All participants were volunteers with no prior acclimatization to cold water or cold environments. Each participant underwent a medical screening by a qualified physician to confirm eligibility and provided written informed consent prior to participation. The cohort was selected to represent operationally relevant individuals likely to utilize Submarine Escape Immersion Equipment (SEIE) suits in real-world scenarios.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy active-duty submariners

Male participants aged 20-25 years

No history of cardiovascular, respiratory, or neurological disorders

Not acclimatized to cold environments or cold water exposure

Provided written

Medically cleared for cold water immersion by a physician prior to participation -

Exclusion criteria

Exclusion Criteria:

History of cardiovascular, respiratory, metabolic, neurological, or musculoskeletal disorders

Regular exposure to cold environments or cold water (cold-acclimatized individuals)

Use of medications that could affect thermoregulation or neuromuscular function

Any skin conditions that may be aggravated by cold water immersion

Inability to provide

Failure to pass pre-exposure medical examination by a study physician

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Full Suit Group

    Participants wearing full-body Submarine Escape Immersion Equipment (SEIE) suits

    Device: Submariner suit

  • Half Suit Group

    Participants wearing half-body Submarine Escape Immersion Equipment (SEIE) suits

    Device: Submariner suit

Interventions

  • DeviceSubmariner suit

    Participants wearing full-body Submarine Escape Immersion Equipment (SEIE) suits

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What researchers measure

Primary outcomes

  1. Core temperature

    Core temp. measured with telemetric pills

    Time frame: two hours

Secondary outcomes

  1. Subjective cold sensation -

    Assessed using a standardized cold discomfort scale during immersion and raft sitting.

    Time frame: two hours

07

Study locations

1 site
  • Israel Naval Medical Institute
    Haifa, 3109601, Israel
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References and documents

Individual participant data

Plan to share: No — The raw, de-identified data collected during the study will be made available upon reasonable request. The dataset contains no personally identifiable information and includes only aggregated physiological and performance measurements. Data will be shared for academic, scientific, or regulatory purposes following review and approval by the principal investigator. Requests can be directed to the corresponding author.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06992050
Lead sponsor
Medical Corps, Israel Defense Force
Responsible party
Dror Ofir (PHD, Medical Corps, Israel Defense Force) — Principal investigator
First posted
May 28, 2025
Start date
Mar 1, 2018
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024
Last update
May 28, 2025

Study contacts

Oren GABAY, MD
principal investigator · ISRAEL NAVAL MEDICAL INSTITUTE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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