Countermeasures for Visual Impairment in Astronauts
STOP-VIIP
Safe and Effective Countermeasures to Reduce Intracranial Pressure and Ameliorate Visual Impairment in Astronauts (STOP VIIP)
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
1 active site
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, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 9, 2021
CompletedFirst Posted
Study publicly available on registry
August 23, 2021
CompletedSeptember 8, 2021
August 1, 2021
1 year
August 9, 2021
August 31, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Change in choroid area
The change in choroid area measured by optical coherence tomography.
Baseline, after 3-days of bed rest
Change in choroid volume
The change in choroid volume measured by optical coherence tomography.
Baseline, after 3-days of bed rest
Study Arms (2)
Control
NO INTERVENTION4 days of strict bed rest
Lower body negative pressure
EXPERIMENTAL4 days of strict bed rest with nightly lower body negative pressure at -20mmHg
Interventions
lower body negative pressure at -20mmHg delivered via a custom designed sleeping sack
Eligibility Criteria
You may qualify if:
- age 18-55
You may not qualify if:
- cardiovascular disease
- ophthalmological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (1)
Hearon CM Jr, Peters K, Dias KA, Macnamara JP, Marshall JET, Campain J, Martin D, Marshal-Goebel K, Levine BD. Assessment of venous pressure by compression sonography of the internal jugular vein during 3 days of bed rest. Exp Physiol. 2023 Dec;108(12):1560-1568. doi: 10.1113/EP091372. Epub 2023 Oct 12.
PMID: 37824038DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Levine, MD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
August 9, 2021
First Posted
August 23, 2021
Study Start
March 1, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
September 8, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share