NCT03192930

Brief Summary

Research hypothesis

  • Prolonged hyperbaric exposure will affect the central nervous system
  • Prolonged hyperbaric exposure will induce inflammatory changes
  • Prolonged hyperbaric exposure will affect fluid regulation in the body Objectives:
  • To investigate the presence of cerebrospinal biochemical markers in blood during prolonged hyperbaric exposure
  • To investigate changes in the quantity of cerebrospinal biochemical markers in blood during decompression after prolonged hyperbaric exposure
  • To investigate the presence of inflammatory markers in blood during prolonged hyperbaric exposure
  • To investigate changes in the quantity of inflammatory markers in blood during decompression after prolonged hyperbaric exposure
  • To investigate if prolonged hyperbaric exposure alters fluid balance in the body

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 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 17, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2018

Completed
Last Updated

April 9, 2019

Status Verified

March 1, 2018

Enrollment Period

10 months

First QC Date

June 14, 2017

Last Update Submit

April 5, 2019

Conditions

Saturation ExposureDecompression Injury

Keywords

HyperbaricSaturationDecompression injuryDecompression sicknessInflammationCentral nervous system injuryDiving medicine

Outcome Measures

Primary Outcomes (1)

  • Concentration of inflammatory and cerebrospinal biochemical markers in blood

    E. g: tau, NfL, GFAP, UCHL-1, VCAM-1, ICAM-1, Endothemin-1 and others

    14 days

Secondary Outcomes (4)

  • Biochemical signs of altered fluid balance in the body

    7 days

  • Changes in lung function

    7 days

  • Presence of Venous gas Emboli (VGE)

    7 days

  • Decompression sickness (DCS)

    7 days

Study Arms (2)

Saturation

Individuals exposed to prolonged hyperbaric exposure

Other: Hyperbaric exposure

Control

Individuals not exposed to prolonged hyperbaric exposure

Interventions

Hyperbaric exposureOTHER

Hyperbaric exposure 4 ATA for 36 hours followed by 70 hours decompression

Saturation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Submariners and divers employed by the Swedish navy and individuals approved by the Swedish navy for work in a hyperbaric environment participating in the Swedish navy saturation diving tests. Submariners and divers employed by the Swedish navy and individuals approved by the Swedish navy for work in a hyperbaric environment not participating in the Swedish navy saturation diving tests.

You may qualify if:

  • Submariners and divers employed by the Swedish navy or individuals approved by the Swedish navy for work in a hyperbaric Environment.
  • Subjects in the intervention group must be participating in the Swedish navy saturation diving tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gothenburg University

Gothenburg, S-405 30, Sweden

Location

Related Publications (1)

  • Rosen A, Gennser M, Oscarsson N, Kvarnstrom A, Sandstrom G, Blennow K, Seeman-Lodding H, Zetterberg H. Biomarkers of neuronal damage in saturation diving-a controlled observational study. Eur J Appl Physiol. 2020 Dec;120(12):2773-2784. doi: 10.1007/s00421-020-04499-y. Epub 2020 Sep 25.

    PMID: 32975632DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum. Plasma.

MeSH Terms

Conditions

Decompression SicknessInflammation

Condition Hierarchy (Ancestors)

BarotraumaWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henrik Zetterberg, PhD

    Göteborg University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 20, 2017

Study Start

March 17, 2017

Primary Completion

January 17, 2018

Study Completion

January 17, 2018

Last Updated

April 9, 2019

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)