NCT06992050

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

6.8 years

First QC Date

May 19, 2025

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Core temperature

    Core temp. measured with telemetric pills

    two hours

Secondary Outcomes (1)

  • Subjective cold sensation -

    two hours

Study Arms (2)

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

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

Full Suit GroupHalf Suit Group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsself-representattion
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israel Naval Medical Institute

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oren GABAY, MD

    ISRAEL NAVAL MEDICAL INSTITUTE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 28, 2025

Study Start

March 1, 2018

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

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.

Locations