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Countermeasures for Visual Impairment in Astronauts (STOP-VIIP)

Primary Purpose

Space Flight Associated Neuro-ocular Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lower body negative pressure
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Space Flight Associated Neuro-ocular Syndrome

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 18-55

Exclusion Criteria:

  • cardiovascular disease
  • ophthalmological disease

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Lower body negative pressure

Arm Description

4 days of strict bed rest

4 days of strict bed rest with nightly lower body negative pressure at -20mmHg

Outcomes

Primary Outcome Measures

Change in choroid area
The change in choroid area measured by optical coherence tomography.
Change in choroid volume
The change in choroid volume measured by optical coherence tomography.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2021
Last Updated
August 31, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05016414
Brief Title
Countermeasures for Visual Impairment in Astronauts
Acronym
STOP-VIIP
Official Title
Safe and Effective Countermeasures to Reduce Intracranial Pressure and Ameliorate Visual Impairment in Astronauts (STOP VIIP)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The visual impairment observed in many astronauts after long duration spaceflight aboard the International Space Station is considered the most important mission-threatening medical problem identified in the last decade of the space program. Between 2012 and 2014, NASA and NSBRI have spent $3-4 million/year investigating the clinical course and underlying mechanisms of this condition, termed the Visual Impairment Intracranial Pressure Syndrome (VIIP) because of its theoretical association with elevated intracranial pressure and central venous pressure. During the previous funding cycle, the investigators for this application performed the first invasive measures of intracranial pressure during acute (head down tilt bedrest and parabolic flight) and chronic (24 hours HDT bedrest) changes in gravitational gradients simulating spaceflight in healthy humans. Novel observations made from those studies determined that 1) there is a large range of central venous pressure experienced normally during changes in posture in daily life; 2) these changes occur within seconds of postural transients from upright to supine and then are stable over time in that position; 3) with acute assumption of simulated microgravity (HDT bedrest), intracranial pressure and central venous pressure goes up slightly from the supine position, but over the next 24 hours, returns toward, and sometimes below the supine value because of spatial compensation within the brain; 4) during true microgravity (parabolic flight), the acute reduction in central venous pressure reduces cerebral outflow resistance and ICP decreases compared to the supine position, though remains above the upright position in 1G. The current hypothesis is that the VIIP syndrome is Not due to a pathologically elevated central venous or intracranial pressure. However, because there is not the usual reduction in pressure typically seen in the upright position on earth, the incessant, low level elevation in ICP (i.e., greater than upright, but less than supine) leads to adaptive changes in the eye which ultimately result in globe flattening, choroidal folds, and visual impairment. Preliminary data suggest that the use of lower body negative pressure (LBNP) can lower ICP while in the head down position, towards the values observed upright. The investigators propose that applying LBNP during sleep in space would be a practical strategy to restore a relevant (though reversed) circadian variability in central venous pressure that would then prevent adaptive changes in the eye. The investigators propose the following hypothesis: Hypothesis 1: Repeated administration of LBNP at night will cause a safe, sustained reduction in central venous pressure while asleep. This restoration of effective circadian variability in central venous pressure will prevent structural changes in the eye induced by microgravity. To test this hypothesis, the long-term efficacy of nightly LBNP (6-8 hrs) to simulate the upright position and prevent structural changes in the eye during four days of bedrest. Comprehensive, non-invasive state-of-the-art imaging will be used to examine the structure of the visual apparatus, using optical coherence tomography combined with invasive direct measurement of CVP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Space Flight Associated Neuro-ocular Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
4 days of strict bed rest
Arm Title
Lower body negative pressure
Arm Type
Experimental
Arm Description
4 days of strict bed rest with nightly lower body negative pressure at -20mmHg
Intervention Type
Other
Intervention Name(s)
Lower body negative pressure
Intervention Description
lower body negative pressure at -20mmHg delivered via a custom designed sleeping sack
Primary Outcome Measure Information:
Title
Change in choroid area
Description
The change in choroid area measured by optical coherence tomography.
Time Frame
Baseline, after 3-days of bed rest
Title
Change in choroid volume
Description
The change in choroid volume measured by optical coherence tomography.
Time Frame
Baseline, after 3-days of bed rest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 18-55 Exclusion Criteria: cardiovascular disease ophthalmological disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Levine, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Countermeasures for Visual Impairment in Astronauts

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