NCT05464758

Brief Summary

In cold weather environments, blood flow to the extremities is significantly reduced, which severely impairs hand function and induces thermal discomfort. Prolonged or repeated cold exposure elicits an adaptive habituation response that is characterized by blunted skin vasoconstriction and thus may be an effective strategy to improve peripheral perfusion, reduce thermal discomfort, and maintain hand function during cold weather military operations. Since mission conditions often involve low ambient temperatures, countermeasures that reduce cold-induced decrements in hand function and thermal comfort are important to enhance Warfighter readiness in cold weather battlefield environments. The goals of this study are to 1) evaluate the effectiveness of cold habituation in improving skin blood flow, hand function, and thermal comfort during cold exposure and 2) identify the mechanisms that contribute to improvements in skin blood flow following habituation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2024

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

July 6, 2022

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Skin blood flow

    Skin blood flow will be measured using non-invasive laser-Doppler flowmetry probes before and during cold exposure. Output (red blood cell flux) will be divided by mean arterial blood pressure to give an index of cutaneous vascular conductance \[CVC, flux/mmHg\].

    8 days

  • Skin temperature

    Skin temperatures \[in °C\] at up to 10 sites on the body will be measured using skin thermistors before and during cold exposure. Hand and foot skin temperatures will also be measured with a thermography imaging camera.

    8 days

  • Manual dexterity - Pegboard

    Pegboard scores will be obtained before and during cold exposure. Scores are the number of pegs placed into the boards.

    3 days

  • Manual dexterity - Minnesota Rate of Manipulation

    Minnesota Rate of Manipulation dexterity scores will be obtained before and during cold exposure. Scores are the time \[in seconds\] required to move small blocks various distances.

    3 days

  • Hand and finger strength

    Pinch and hand strength \[in kg\] will be measured using a pinch meter and grip strength device (dynamometer). Participants will complete three pinch strength tests and one grip strength test before and during cold exposure.

    3 days

  • Cold perception

    Ratings of thermal comfort, thermal sensation, and pain perception \[in arbitrary units\] will be assessed using visual analogue scales before and during cold exposure.

    5 days

Secondary Outcomes (5)

  • Metabolic heat production

    5 days

  • Body core temperature

    5 days

  • Blood pressure

    12 days

  • Plasma norepinephrine

    3 days

  • Heart rate

    12 days

Study Arms (1)

Cold habituation

EXPERIMENTAL

8-day cold habituation

Other: Repeated cold exposure

Interventions

8 consecutive days of exposure to 8°C air for 120 minutes each day

Cold habituation

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, age 18-39
  • In good health as determined by OMSO (Office of Medical Support and Oversight)
  • Willing to refrain from exercise and caffeinated or alcoholic beverages for 12 hours before each testing session
  • Willing to refrain from smoking or tobacco use 8 hours before each testing session

You may not qualify if:

  • History of cold injuries of any severity (e.g., frostbite, trench foot, chilblains).
  • Raynaud's syndrome.
  • Cold-induced asthma/bronchospasm
  • Previous hand/finger injuries that impair dexterity and hand function.
  • Metal hardware (plates/screws) in the forearms and hands.
  • Current use of medications or dietary supplements that could alter cardiovascular, thermoregulatory, or vascular control (e.g., anti-hypertensives, statins).
  • Known allergies to medical adhesives.
  • Heart, lung, kidney, muscle, or nerve disorder(s)
  • A planned MRI during the study or within 2 days after completing a cold test.
  • Women who are pregnant, planning to become pregnant, or breastfeeding.
  • Not willing to have small areas of skin on the body shaved (if deemed necessary for attachment of study instrumentation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.S. Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

Study Officials

  • Billie K Alba, Ph.D.

    United States Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 19, 2022

Study Start

August 1, 2022

Primary Completion

September 13, 2024

Study Completion

September 13, 2024

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations