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NCT05016414: STOP-VIIP

Countermeasures for Visual Impairment in Astronauts

Completed NA Last updated 8 September 2021
What this trial tests

NA trial testing Lower body negative pressure in Space Flight Associated Neuro-ocular Syndrome in 10 participants. Completed in 1 March 2020.

Timeline
1 March 2019
Primary endpoint
1 March 2020
1 March 2020

Quick facts

Lead sponsorUniversity of Texas Southwestern Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposebasic science
Enrollment10
Start date1 March 2019
Primary completion1 March 2020
Estimated completion1 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 55, any sex, with Space Flight Associated Neuro-ocular Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is being done to prevent changes in the vision of astronauts during prolonged residence on the International Space Station or a mission to Mars. This project will provide data about the efficacy of lower body negative pressure to mimic daily upright posture by intermittently lowering central venous pressure while in simulated microgravity (3 days of bed rest). The investigators expect that 3 days of bed rest will increase choroid thickness, and choroid area. The investigators hypothesize that nightly LBNP (-20mmHg) will prevent these changes.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effect of Nightly Lower Body Negative Pressure on Choroid Engorgement in a Model of Spaceflight-Associated Neuro-ocular Syndrome: A Randomized Crossover Trial.
    Hearon CM, Dias KA, Babu G, Marshall JET, et al · · 2022 · cited 17× · PMID 34882176 · DOI 10.1001/jamaophthalmol.2021.5200
  2. Assessment of venous pressure by compression sonography of the internal jugular vein during 3 days of bed rest.
    Hearon CM, Peters K, Dias KA, Macnamara JP, et al · · 2023 · cited 4× · PMID 37824038 · DOI 10.1113/ep091372

Verify or expand the search:

Other trials of Lower body negative pressure

Trials testing the same drug.

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05016414.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing