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NCT06405282 · ClinicalTrials.gov registry record
Weightlessness Associated Cephalad Fluid Shifts; The Potential to Evaluate Venous and Lymphatic Dysfunction
A clinical trial, sponsored by Nova Southeastern University.
- Completed
- Registry status
- 15
- Enrollment target
NCT06405282 is a clinical trial that has completed, run by Nova Southeastern University. The registered enrollment target is 15 participants.
The verdict
NCT06405282 has completed, sponsored by Nova Southeastern University.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
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
Interventions
- OTHER Manual Lymphatic Drainage
- DEVICE Near infrared spectroscopy
- DEVICE Temperature
- DEVICE Tissue Dialectic Constant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-04-14 |
| Est. Completion | 2022-06-25 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06405282
The ClinicalTrials.gov registry entry for NCT06405282 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nova Southeastern University, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Manual Lymphatic Drainage is the first listed.
NCT06405282 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06405282 about?
NCT06405282 is a clinical study titled "Weightlessness Associated Cephalad Fluid Shifts; The Potential to Evaluate Venous and Lymphatic Dysfunction". 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 othe...
What is the current status of trial NCT06405282?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2022-04-14. Estimated completion is 2022-06-25.
What interventions are being tested in trial NCT06405282?
The interventions under investigation include: Manual Lymphatic Drainage (OTHER), Near infrared spectroscopy (DEVICE), Temperature (DEVICE), Tissue Dialectic Constant (DEVICE).
Who is sponsoring clinical trial NCT06405282?
This trial is sponsored by Nova Southeastern University, which has 71 total clinical trials registered on ClinicalTrials.gov.
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