Weightlessness Associated Cephalad Fluid Shifts; The Potential to Evaluate Venous and Lymphatic Dysfunction
Public ClinicalTrials.gov record NCT06405282. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
The Use of Non-Invasive Imaging Devices (NIID) to Detect Temperature Differentiation and Lymphatic/Venous Flow to the Head and Neck During Head Down Tilt Position Before and After Manual Lymphatic Drainage: The NIID Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In the weightlessness of space and significant alterations of terrestrial 1 g (1 gravity equivalent) head-to-foot hydrostatic pressure gradients, astronauts experience a dramatic fluid redistribution of \~ 2 liters from the legs to the head and neck within the first 24-48 hours of flight, among other cardiovascular and physiologic system adaptations. After only 4 days in the weightlessness of low earth orbit (LEO), changes can be seen in baroreceptor responsiveness, causing orthostatic hypotension upon subsequent return to Earth. Fluid shifts may also result in headaches, congestion or facial puffiness that can contribute to deteriorating sleep patterns. The ability to manage, mitigate, or offset these fluid shifts is vital to maintain nominal health for short and long duration space flight and potentially improve readaptation to terrestrial gravity or other surface gravity fields, such as the moon or Mars. Fluid shifts towards the cephalic region during microgravity have been speculated to contribute towards spaceflight associated neuro-ocular syndrome (SANS). SANS is a distinct, microgravity-induced phenomenon of neuro-ophthalmic findings observed in astronauts following long-duration spaceflight including choroidal folds, optic disc edema, posterior globe flattening, refractive shift, and cerebral fluid shifts noted to be persistent at 6-month post-flight MRI scans. Thus, noninvasive approaches to studying real-time fluid shifts in weightlessness could serve as critical areas of research to further SANS study and effective countermeasure protocol development. For continuous fluid shift monitoring and management, the goal is to establish baseline assessments utilizing real-time point- of-care noninvasive imaging devices (NIID). Manual lymphatic drainage (MLD) therapy reduces lymphatic fluid in the affected limb, head, and neck to improve function and prevent progression of fluid build-up. MLD is a therapeutic massage that delivers light pressure through the skin to stimulate lymphatic vessel function. Randomized controlled trials have demonstrated statistically significant improvements in lymphatic function and pain following MLD. The main objectives of this pilot, retrospective study were to use NIID to examine temperature differential alterations, superficial venous flow patterns (head, neck, upper torso), and venous flow patterns along the lymphatic ventromedial bundles of the medial calves and thighs when in the 6-degree head down tilt (HDT) validated space analogue position and to analyze the effect of MLD therapy administered in the HDT position on lymphatic flow and temperature. HDT is the best validated space analogue currently available for evaluation of fluid redistribution in a timely manner.
Study identification
- NCT ID
- NCT06405282
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Interventions
- Manual Lymphatic Drainage Other
- Near infrared spectroscopy Device
- Temperature Device
- Tissue Dialectic Constant Device
Other · Device
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 13, 2022
- Primary completion
- Jun 24, 2022
- Completion
- Jun 24, 2022
- Last update posted
- May 7, 2024
2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nova Southeastern University | Fort Lauderdale | Florida | 33328 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06405282, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06405282 live on ClinicalTrials.gov.