Fluid Retention TissueNIIDNCT06405282
Weightlessness Associated Cephalad Fluid Shifts; The Potential to Evaluate Venous and Lymphatic Dysfunction
An observational study of Fluid Retention Tissue and Perfusion; Complications, run by Nova Southeastern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid Retention Tissue, Perfusion; Complications
- What is being tested?
- Manual Lymphatic Drainage, Near infrared spectroscopy and Temperature
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 25 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy students between the ages of 18 and 45.
Who may be able to join
- Students at Nova Southeastern University
- Aged 18-45 years
- Body Mass Index ranging from 18.5 to 24.9
- No known lymphatic dysfunction
- Written informed consent
Who cannot join
- On blood pressure medications
- On vasodilation medications
- Uses any form of nicotine
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University
Fort Lauderdale, Florida, 33328
About this study
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
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.
Read the detailed description
Under the influence of standard developmental physiology on the Earth's surface (1 g), 70% of body fluids reside below the level of the heart. The lymphatic system has the capacity and capability to transport fluid from distal to proximal in an upward manner, against gravity and tissue pressure gradients, via lymphangion contractility, leg muscle contraction, respiratory and chest wall function, thus augmenting a "suction effect" for pumping lymphatic fluid within the subatmospheric pressure tissue distribution zones (the Guyton principle). Lymphatic drainage of the head and neck must be assisted by gravity, since these regions are above the level of the heart. In the weightlessness of space and significant alterations of terrestrial 1 g 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 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 NIID.
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 case series were to use 4 standard-of-care NIIDs 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 HDT space analogue position and to analyze the effect of MLD therapy administered in the HDT position on lymphatic flow and temperature. We hypothesize that dermal venous and lymphatic flow patterns of the head, neck, upper torso, and ventromedial bundle flow patterns shifted to cephalad (dermal interstitial fluid increase) and were reversed following MLD therapy in the 6-degree HDT position. More specifically, MLD therapy could alter lymphatic contractility flow patterns and interstitial fluid, in addition to temperature differentials, in the 6-degree HDT position.
The following imaging devices were used to measure fluid redistribution and temperature in the HDT: near-infrared spectroscopy imaging device (SnapShotNIR, Kent Imaging, Calgary, Canada) to capture perfusion changes through and superficial oxygenation saturation measurements; long-wave infrared and wound imaging device (WoundVision Scout, WoundVision, Indianapolis, IN) to capture thermal images measuring physiological temperature differentiation; Lymphatic fluid scanning device (LymphScanner, Delfin Technologies, Miami, FL, USA) to measure percentage water content [tissue dielectric constant (TDC)] consistent with lymphatic flow patterns and interstitial fluid alterations related to positioning.
- Conditions
- Fluid Retention Tissue, Perfusion; Complications
- Being tested
- Manual Lymphatic Drainage, Near infrared spectroscopy, Temperature, Tissue Dialectic Constant
- Keywords
- dermal flow, venous flow, fluid shift, manual lymphatic drainage, blood circulation, space simulation, diagnostic imaging, tissue temperature gradient
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic DrainageOther
MLD is a gentle manual technique used to decongest swollen areas and redirect lymphatic flow to non-congested areas
Near infrared spectroscopyDevice
Also called Kent Snapshot
Oxygen saturation measurement
TemperatureDevice
Also called Long wave infrared, Wound Vision Scout
Thermal imaging
Tissue Dialectic ConstantDevice
Also called TDC, Delfin Lymphscanner
TDC captured by lymphatic fluid scanning device
| Study group | Role | What they receive |
|---|---|---|
| Healthy students of the Health Professions Division of NSU | Participants arrived at a predesignated room and acclimated to the ambient temperature for 15 minutes. Baseline heart rate, blood pressure, respiration rate, and oxygen saturation were taken and monitored throughout the data collection process. Participants were assessed in the HDT position (validated simulated weightlessness) for 3 hours and 45 minutes. Baseline image assessments were taken 1 minute after assuming the HDT position. Subsequent image assessments were taken every 30 minutes thereafter. Each image acquisition requires ~20 seconds and was performed by 1 of 4 trained imagers. Participants received 15 minutes of an established MLD protocol to the head, neck, and thorax before moving out of position. Immediately post-MLD, reassessment with the devices occurred. A follow-up reassessment was taken with the devices 30 minutes after MLD in the sitting position to assess potential changes and resolution of any symptoms experienced following a return to gravity environment. Receives: Other: Manual Lymphatic Drainage; Device: Near infrared spectroscopy; Device: Temperature; Device: Tissue Dialectic Constant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change (%) in TDC level from baseline
TDC is a measurement of local tissue water content. The lymphatic fluid scanner will assess TDC levels at the timepoints listed below. The outcome measure is the percent change in these levels to assess change in interstitial fluid in simulated microgravity; the unit is percentage.
Measured: Baseline, post-30 minutes, post-60 minutes, post-90 minutes, post-120 minutes, post-150 minutes, post-180 minutes, post-195 minutes (post-MLD), and post-225 minutes (30-minutes-post-MLD)
Percent change (%) in tissue oxygenation saturation level from baseline
Tissue oxygenation saturation is an indicator of perfusion changes. NIRS will assess tissue oxygenation at the timepoints listed below. The outcome measure is the percent change in these levels to assess perfusion changes in simulated microgravity; the unit is percentage.
Measured: Baseline, post-30 minutes, post-60 minutes, post-90 minutes, post-120 minutes, post-150 minutes, post-180 minutes, post-195 minutes (post-MLD), and post-225 minutes (30-minutes-post-MLD).
Percent change (%) in tissue temperature gradient from baseline
Tissue temperature gradient measures the change in temperature at an area of interest compared to surrounding tissues. Fluid shifts are associated with tissue temperature alterations. LWIT will assess the tissue temperature gradient at the timepoints listed below. The outcome measure is the percent change in temperature gradients to assess changes in thermal energy at an area of interest in simulated microgravity; the unit is percentage.
Measured: Baseline,post-30 minutes, post-60 minutes, post-90 minutes, post-120 minutes, post-150 minutes, post-180 minutes, post-195 minutes (post-MLD), and post-225 minutes (30-minutes-post-MLD).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start14 Apr 2022
- Primary completion25 Jun 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fluid Retention TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Barnhart, Nova Southeastern University
- Investigators
- Heather Barnhart, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405282
- Sponsor's protocol ID
- 2022-124
- Acronym
- NIID
- Status last verified
- May 2024
- First submitted
- 4 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undecided, plan to publish summary data in peer-reviewed journal
Publications
Michel CC. Starling: the formulation of his hypothesis of microvascular fluid exchange and its significance after 100 years. Exp Physiol. 1997 Jan;82(1):1-30. doi: 10.1113/expphysiol.1997.sp004000. No abstract available.
PubMed 9023503Debiec-Bak A, Skrzek A , Prof, Wozniewski M , Prof, Malicka I. Using Thermography in the Diagnostics of Lymphedema: Pilot Study. Lymphat Res Biol. 2020 Jun;18(3):247-253. doi: 10.1089/lrb.2019.0002. Epub 2019 Nov 19.
PubMed 31742482Barnhart H, Aviles F Jr, Pannunzio J, Sirkis N, Hubbard C, Hardigan P, Ginsburg S, Mayrovitz H, Eckert KA, Melin MM. Using noninvasive imaging to assess manual lymphatic drainage on lymphatic/venous responses in a spaceflight analog. NPJ Microgravity. 2024 Oct 3;10(1):93. doi: 10.1038/s41526-024-00429-w.
PubMed 39362907
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06405282
- Acronym / sponsor ID
- NIID / 2022-124
- Conditions
- Fluid Retention Tissue, Perfusion; Complications
- Keywords
- dermal flow, venous flow, fluid shift, manual lymphatic drainage, blood circulation, space simulation, diagnostic imaging, tissue temperature gradient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Under the influence of standard developmental physiology on the Earth's surface (1 g), 70% of body fluids reside below the level of the heart. The lymphatic system has the capacity and capability to transport fluid from distal to proximal in an upward manner, against gravity and tissue pressure gradients, via lymphangion contractility, leg muscle contraction, respiratory and chest wall function, thus augmenting a "suction effect" for pumping lymphatic fluid within the subatmospheric pressure tissue distribution zones (the Guyton principle). Lymphatic drainage of the head and neck must be assisted by gravity, since these regions are above the level of the heart. In the weightlessness of space and significant alterations of terrestrial 1 g 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 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 NIID.
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 case series were to use 4 standard-of-care NIIDs 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 HDT space analogue position and to analyze the effect of MLD therapy administered in the HDT position on lymphatic flow and temperature. We hypothesize that dermal venous and lymphatic flow patterns of the head, neck, upper torso, and ventromedial bundle flow patterns shifted to cephalad (dermal interstitial fluid increase) and were reversed following MLD therapy in the 6-degree HDT position. More specifically, MLD therapy could alter lymphatic contractility flow patterns and interstitial fluid, in addition to temperature differentials, in the 6-degree HDT position.
The following imaging devices were used to measure fluid redistribution and temperature in the HDT: near-infrared spectroscopy imaging device (SnapShotNIR, Kent Imaging, Calgary, Canada) to capture perfusion changes through and superficial oxygenation saturation measurements; long-wave infrared and wound imaging device (WoundVision Scout, WoundVision, Indianapolis, IN) to capture thermal images measuring physiological temperature differentiation; Lymphatic fluid scanning device (LymphScanner, Delfin Technologies, Miami, FL, USA) to measure percentage water content [tissue dielectric constant (TDC)] consistent with lymphatic flow patterns and interstitial fluid alterations related to positioning.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy students of the Health Professions Division of NSU | – | Other: Manual Lymphatic Drainage, Device: Near infrared spectroscopy, Device: Temperature, Device: Tissue Dialectic ConstantParticipants arrived at a predesignated room and acclimated to the ambient temperature for 15 minutes. Baseline heart rate, blood pressure, respiration rate, and oxygen saturation were taken and monitored throughout the data collection process. Participants were assessed in the HDT position (validated simulated weightlessness) for 3 hours and 45 minutes. Baseline image assessments were taken 1 minute after assuming the HDT position. Subsequent image assessments were taken every 30 minutes thereafter. Each image acquisition requires ~20 seconds and was performed by 1 of 4 trained imagers. Participants received 15 minutes of an established MLD protocol to the head, neck, and thorax before moving out of position. Immediately post-MLD, reassessment with the devices occurred. A follow-up reassessment was taken with the devices 30 minutes after MLD in the sitting position to assess potential changes and resolution of any symptoms experienced following a return to gravity environment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy students between the ages of 18 and 45.
Key inclusion criteria (5 listed)
- Students at Nova Southeastern University
- Aged 18-45 years
- Body Mass Index ranging from 18.5 to 24.9
- No known lymphatic dysfunction
- Written informed consent
Key exclusion criteria (3 listed)
- On blood pressure medications
- On vasodilation medications
- Uses any form of nicotine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Lymphatic DrainageMLD is a gentle manual technique used to decongest swollen areas and redirect lymphatic flow to non-congested areas | Other | Healthy students of the Health Professions Division of NSU |
| Near infrared spectroscopyAlso: Kent SnapshotOxygen saturation measurement | Device | Healthy students of the Health Professions Division of NSU |
| TemperatureAlso: Long wave infrared, Wound Vision ScoutThermal imaging | Device | Healthy students of the Health Professions Division of NSU |
| Tissue Dialectic ConstantAlso: TDC, Delfin LymphscannerTDC captured by lymphatic fluid scanning device | Device | Healthy students of the Health Professions Division of NSU |
Primary outcome
Percent change (%) in TDC level from baseline
Time frame: Baseline, post-30 minutes, post-60 minutes, post-90 minutes, post-120 minutes, post-150 minutes, post-180 minutes, post-195 minutes (post-MLD), and post-225 minutes (30-minutes-post-MLD)
TDC is a measurement of local tissue water content. The lymphatic fluid scanner will assess TDC levels at the timepoints listed below. The outcome measure is the percent change in these levels to assess change in interstitial fluid in simulated microgravity; the unit is percentage.
Percent change (%) in tissue oxygenation saturation level from baseline
Time frame: Baseline, post-30 minutes, post-60 minutes, post-90 minutes, post-120 minutes, post-150 minutes, post-180 minutes, post-195 minutes (post-MLD), and post-225 minutes (30-minutes-post-MLD).
Tissue oxygenation saturation is an indicator of perfusion changes. NIRS will assess tissue oxygenation at the timepoints listed below. The outcome measure is the percent change in these levels to assess perfusion changes in simulated microgravity; the unit is percentage.
Percent change (%) in tissue temperature gradient from baseline
Time frame: Baseline,post-30 minutes, post-60 minutes, post-90 minutes, post-120 minutes, post-150 minutes, post-180 minutes, post-195 minutes (post-MLD), and post-225 minutes (30-minutes-post-MLD).
Tissue temperature gradient measures the change in temperature at an area of interest compared to surrounding tissues. Fluid shifts are associated with tissue temperature alterations. LWIT will assess the tissue temperature gradient at the timepoints listed below. The outcome measure is the percent change in temperature gradients to assess changes in thermal energy at an area of interest in simulated microgravity; the unit is percentage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 9023503Michel CC. Starling: the formulation of his hypothesis of microvascular fluid exchange and its significance after 100 years. Exp Physiol. 1997 Jan;82(1):1-30. doi: 10.1113/expphysiol.1997.sp004000. No abstract available.
- Background: PubMed 31742482Debiec-Bak A, Skrzek A , Prof, Wozniewski M , Prof, Malicka I. Using Thermography in the Diagnostics of Lymphedema: Pilot Study. Lymphat Res Biol. 2020 Jun;18(3):247-253. doi: 10.1089/lrb.2019.0002. Epub 2019 Nov 19.
- Derived from this study: PubMed 39362907Barnhart H, Aviles F Jr, Pannunzio J, Sirkis N, Hubbard C, Hardigan P, Ginsburg S, Mayrovitz H, Eckert KA, Melin MM. Using noninvasive imaging to assess manual lymphatic drainage on lymphatic/venous responses in a spaceflight analog. NPJ Microgravity. 2024 Oct 3;10(1):93. doi: 10.1038/s41526-024-00429-w.
- Individual participant dataSharing planned: Undecided. Undecided, plan to publish summary data in peer-reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Barnhart, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Retention Tissue and Perfusion; Complications, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change (%) in TDC level from baseline (time frame: Baseline, post-30 minutes, post-60 minutes, post-90 minutes, post-120 minutes, post-150 minutes, post-180 minutes, post-195 minutes (post-MLD), and post-225 minutes (30-minutes-post-MLD)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06405282, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.