Sedentary BehaviorSWITCHNCT05316571
Sitting Interruption and Whole-body Cardiovascular Health
A study testing One 5-Minute Walking Bout Each Hour, One 15-Minute Standing Bout Each Hour and One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour in people with Sedentary Behavior and Sedentary Time, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Sedentary Time
- What is being tested?
- One 5-Minute Walking Bout Each Hour, One 15-Minute Standing Bout Each Hour and One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 30 May 2026
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 30-60 years
- Insufficiently active: self-reported exercise <90 minutes per week for the past 3 months
- Sedentary: self-reported sitting >8 hours per day
- Self-reported ability to walk 4 blocks and climb 2 flights of stairs
- Possession of cellular phone able to receive text messages
Who cannot join
- Use of assisted-walking devices
- Comorbid condition that would limit the ability to reduce sedentary behavior (e.g., musculoskeletal condition, current chemotherapy)
- Plans for major surgery within next 3 months
- Recent history (<1 year) of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
- Recent (< 1 year) or planned bariatric surgery
- Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg
Show all 11Show fewer
- Current or recent (within last 6 months) pregnancy; current or recent (within last 3 months) breastfeeding
- Morbidly obesity (BMI >40 kg/m^2) or underweight (BMI <18.5 kg/m^2)
- Use of anti-hypertensive drugs
- Use of glucose-controlling medication
- Heavy alcohol consumption (>15 drinks per week)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Sitting Interruption and Whole-body Cardiovascular Health: Linking Physiological Responses to Risk Behaviors
There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. This study will identify and test the physiological effects of several sedentary behavior interruption strategies and explore the feasibility (i.e., likelihood of an individual performing the requested activities) of those strategies to inform the development of public policy surrounding sedentary behavior interruption. Long-term, the findings of this study will inform a large clinical trial that can test whether sedentary behavior reduction can decrease cardiovascular disease risk.
Read the detailed description
Sedentary behaviors (SB) are biologically distinct but understudied heart disease risk factors. National and international agencies have concluded that the level of evidence for an overall and dose-response association between SB and heart disease mortality is moderate-strong. These agencies do not provide specific recommendations for breaking-up SB, though do call on the research community to facilitate policy development by establishing biological plausibility, identifying the optimal dose for SB substitution strategies, and conducting randomized clinical trials to test the efficacy of these strategies. Accordingly, the goal of this study is to identify mechanism-informed, socioecological-based SB substitution recommendations to reduce heart disease risk. To achieve this goal, two aims will be addressed. Aim 1 will identify a feasible SB substitution strategy to prevent the negative cardiovascular responses to prolonged SB (i.e., strategies that people will actually follow). Adverse cardiovascular responses to prolonged SB will be measured using aortic arterial stiffness (AS), a noninvasive test that predicts future heart disease. To accomplish this aim, middle-aged (30-60 years) participants will provide written informed consent, prior to the measurement of aortic AS and associated mechanistic responses to the following over 4 hours, in a randomized crossover manner: (i) SB with a 5-minute walk break once per hour; (ii) SB with a 15-minute standing break once per hour; (iii) SB with two breaks per hour, alternating between a 5-minute walk and a 15-minute stand; and (iv) SB with no breaks (control). These strategies were selected based on extensive prior work by the investigators, and because they are feasible, which is a key component of this study. SB reduction strategies will only decrease heart disease risk if people are willing to adhere to future SB substitution recommendations. To increase the likelihood of feasibility and long-term adherence, Aim 2 will evaluate the determinants of SB using a socioecological model. This recognizes that behavior change is likely to be limited if the physical and sociocultural environments do not support the behavior change. To accomplish Aim 2, a combined inductive-deductive qualitative approach will be used. Participants who complete Aim 1 will participate in focus groups (min 3, max 8 participants/group). Crucially, the outcomes from this proposal will be instrumental in helping to design a subsequent clinical trial to test a mechanism-informed yet feasible SB reduction intervention, and in doing so directly support the development of SB policy.
- Conditions
- Sedentary Behavior, Sedentary Time
- Being tested
- One 5-Minute Walking Bout Each Hour, One 15-Minute Standing Bout Each Hour, One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour, Uninterrupted Sitting
- Keywords
- Sedentary Behavior, Interruption, Sitting, Cardiovascular, Arterial Stiffness, Pulse Wave Velocity
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One 5-Minute Walking Bout Each HourBehavioural
One 5-minute light intensity walking break per hour throughout the 4-hour SB condition
One 15-Minute Standing Bout Each HourBehavioural
One 15-minute standing break per hour throughout the 4-hour SB condition
One 5-Minute Walking Bout and One 15-Minute Standing Bout Each HourBehavioural
Two breaks per hour throughout the 4-hour SB condition, alternating between a 5-minute light intensity walking break and a 15-minute standing break
Uninterrupted SittingBehavioural
No breaks will be provided throughout the 4-hour SB condition. This will be used as the control condition
| Study group | Role | What they receive |
|---|---|---|
| One 5-Minute Walking Bout Each Hour | Active comparator | A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary.
The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed. Receives: Behavioral: One 5-Minute Walking Bout Each Hour |
| One 15-Minute Standing Bout Each Hour | Active comparator | A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary.
The interruption strategy includes breaking up the 4-hour sitting bout with one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed. Receives: Behavioral: One 15-Minute Standing Bout Each Hour |
| One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour | Active comparator | A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary.
The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout and one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed. Receives: Behavioral: One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour |
| Uninterrupted Sitting | Active comparator | A 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary.
This uninterrupted sedentary bout will serve as a control. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed. Receives: Behavioral: Uninterrupted Sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Carotid-femoral Pulse Wave Velocity (cfPWV)
cfPWV (m/sec) will be measured between the carotid and femoral arteries, using a collar around the neck and a cuff around the thigh, with the participant in a supine position. cfPWV is calculated by dividing path length by pulse transit time and reported as the mean of three measurements
Measured: Measurements will be taken immediately before and after each 4-hour SB condition
Secondary outcomes (2)
Change in Heart-middle Cerebral Artery Pulse Wave Velocity (Brain PWV)
Brain PWV (cm/sec) is the velocity at which a pressure wave travels between the heart and cerebrovascular system. Brain PWV will be calculated from the ECG r-wave to the foot of the Cerebral Blood Flow Velocity (CBFV) waveform
Measured: Measurements will occur continuously throughout each of the 4-hour SB conditions
Mean Change in Femoral-ankle PWV
Femoral-ankle PWV (m/sec) is the velocity at which a pressure wave travels between the femoral-ankle arterial segments. Femoral-ankle PWV is calculated by dividing path length by pulse transit time and reported as the mean of three measurements
Measured: Measurements will be taken immediately before and after each 4-hour SB condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start15 Aug 2022
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will complete four, 4-hour SB bouts with the following conditions: (i) one 5-minute walk break per hour; (ii) one 15-minute standing break per hour; (iii) two breaks per hour, alternating between 5 minutes of walking and 15 minutes of standing; and (iv) SB with no breaks (control). The order of intervention will be assigned in a randomized, crossover manner with 24 potential unique sequences of intervention assignment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Erik Hanson, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316571
- Sponsor's protocol ID
- 21-3195
- Other IDs
- 1R01HL157187-01A1
- Acronym
- SWITCH
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
Publications
Higgins S, Cowley ES, Paterson C, Hanson ED, Dave GJ, Meyer ML, Lin FC, Gibbs BB, Vu M, Stoner L. Protocol for a study on Sitting with Interruption and Whole-Body Cardiovascular Health (SWITCH) in middle-aged adults. Contemp Clin Trials. 2023 Feb;125:107048. doi: 10.1016/j.cct.2022.107048. Epub 2022 Dec 9.
PubMed 36509249
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitting Interruption and Whole-body Cardiovascular Health: Linking Physiological Responses to Risk Behaviors
- ClinicalTrials.gov ID
- NCT05316571
- Acronym / sponsor ID
- SWITCH / 21-3195
- Conditions
- Sedentary Behavior, Sedentary Time
- Keywords
- Sedentary Behavior, Interruption, Sitting, Cardiovascular, Arterial Stiffness, Pulse Wave Velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 7 Apr 2022 (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.
There is strong evidence for the association between sedentary behaviors and cardiovascular diseases such as coronary heart disease and stroke. However, the public currently has no clear guidance on how to limit or interrupt their sedentary behaviors. This study will identify and test the physiological effects of several sedentary behavior interruption strategies and explore the feasibility (i.e., likelihood of an individual performing the requested activities) of those strategies to inform the development of public policy surrounding sedentary behavior interruption. Long-term, the findings of this study will inform a large clinical trial that can test whether sedentary behavior reduction can decrease cardiovascular disease risk.
Detailed description
Sedentary behaviors (SB) are biologically distinct but understudied heart disease risk factors. National and international agencies have concluded that the level of evidence for an overall and dose-response association between SB and heart disease mortality is moderate-strong. These agencies do not provide specific recommendations for breaking-up SB, though do call on the research community to facilitate policy development by establishing biological plausibility, identifying the optimal dose for SB substitution strategies, and conducting randomized clinical trials to test the efficacy of these strategies. Accordingly, the goal of this study is to identify mechanism-informed, socioecological-based SB substitution recommendations to reduce heart disease risk. To achieve this goal, two aims will be addressed. Aim 1 will identify a feasible SB substitution strategy to prevent the negative cardiovascular responses to prolonged SB (i.e., strategies that people will actually follow). Adverse cardiovascular responses to prolonged SB will be measured using aortic arterial stiffness (AS), a noninvasive test that predicts future heart disease. To accomplish this aim, middle-aged (30-60 years) participants will provide written informed consent, prior to the measurement of aortic AS and associated mechanistic responses to the following over 4 hours, in a randomized crossover manner: (i) SB with a 5-minute walk break once per hour; (ii) SB with a 15-minute standing break once per hour; (iii) SB with two breaks per hour, alternating between a 5-minute walk and a 15-minute stand; and (iv) SB with no breaks (control). These strategies were selected based on extensive prior work by the investigators, and because they are feasible, which is a key component of this study. SB reduction strategies will only decrease heart disease risk if people are willing to adhere to future SB substitution recommendations. To increase the likelihood of feasibility and long-term adherence, Aim 2 will evaluate the determinants of SB using a socioecological model. This recognizes that behavior change is likely to be limited if the physical and sociocultural environments do not support the behavior change. To accomplish Aim 2, a combined inductive-deductive qualitative approach will be used. Participants who complete Aim 1 will participate in focus groups (min 3, max 8 participants/group). Crucially, the outcomes from this proposal will be instrumental in helping to design a subsequent clinical trial to test a mechanism-informed yet feasible SB reduction intervention, and in doing so directly support the development of SB policy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Each participant will complete four, 4-hour SB bouts with the following conditions: (i) one 5-minute walk break per hour; (ii) one 15-minute standing break per hour; (iii) two breaks per hour, alternating between 5 minutes of walking and 15 minutes of standing; and (iv) SB with no breaks (control). The order of intervention will be assigned in a randomized, crossover manner with 24 potential unique sequences of intervention assignment.
| Arm | Type | Receives |
|---|---|---|
| One 5-Minute Walking Bout Each Hour | Active comparator | Behavioral: One 5-Minute Walking Bout Each HourA 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed. |
| One 15-Minute Standing Bout Each Hour | Active comparator | Behavioral: One 15-Minute Standing Bout Each HourA 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. The interruption strategy includes breaking up the 4-hour sitting bout with one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed. |
| One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour | Active comparator | Behavioral: One 5-Minute Walking Bout and One 15-Minute Standing Bout Each HourA 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. The interruption strategy includes breaking up the 4-hour sitting bout with one 5-minute light intensity walking bout and one 15-minute standing bout each hour. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed. |
| Uninterrupted Sitting | Active comparator | Behavioral: Uninterrupted SittingA 4-hour sedentary behavior bout, during which the participant remains seated while watching a non-stimulatory documentary. This uninterrupted sedentary bout will serve as a control. Each participant will be re-randomized to any of the non-completed arms after completion of the initial 4-hour sitting bout and interruption strategy until all arms have been completed. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 30-60 years
- Insufficiently active: self-reported exercise <90 minutes per week for the past 3 months
- Sedentary: self-reported sitting >8 hours per day
- Self-reported ability to walk 4 blocks and climb 2 flights of stairs
- Possession of cellular phone able to receive text messages
Key exclusion criteria (11 listed)
- Use of assisted-walking devices
- Comorbid condition that would limit the ability to reduce sedentary behavior (e.g., musculoskeletal condition, current chemotherapy)
- Plans for major surgery within next 3 months
- Recent history (<1 year) of ischemic heart disease, chronic heart failure, stroke, or chronic kidney disease
- Recent (< 1 year) or planned bariatric surgery
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 |
|---|---|---|
| One 5-Minute Walking Bout Each HourOne 5-minute light intensity walking break per hour throughout the 4-hour SB condition | Behavioural | One 5-Minute Walking Bout Each Hour |
| One 15-Minute Standing Bout Each HourOne 15-minute standing break per hour throughout the 4-hour SB condition | Behavioural | One 15-Minute Standing Bout Each Hour |
| One 5-Minute Walking Bout and One 15-Minute Standing Bout Each HourTwo breaks per hour throughout the 4-hour SB condition, alternating between a 5-minute light intensity walking break and a 15-minute standing break | Behavioural | One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour |
| Uninterrupted SittingNo breaks will be provided throughout the 4-hour SB condition. This will be used as the control condition | Behavioural | Uninterrupted Sitting |
Primary outcome
Mean Change in Carotid-femoral Pulse Wave Velocity (cfPWV)
Time frame: Measurements will be taken immediately before and after each 4-hour SB condition
cfPWV (m/sec) will be measured between the carotid and femoral arteries, using a collar around the neck and a cuff around the thigh, with the participant in a supine position. cfPWV is calculated by dividing path length by pulse transit time and reported as the mean of three measurements
2 secondary outcomes
Change in Heart-middle Cerebral Artery Pulse Wave Velocity (Brain PWV)
Time frame: Measurements will occur continuously throughout each of the 4-hour SB conditions
Mean Change in Femoral-ankle PWV
Time frame: Measurements will be taken immediately before and after each 4-hour SB condition
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 25 Sep 2026.
- Background: PubMed 36509249Higgins S, Cowley ES, Paterson C, Hanson ED, Dave GJ, Meyer ML, Lin FC, Gibbs BB, Vu M, Stoner L. Protocol for a study on Sitting with Interruption and Whole-Body Cardiovascular Health (SWITCH) in middle-aged adults. Contemp Clin Trials. 2023 Feb;125:107048. doi: 10.1016/j.cct.2022.107048. Epub 2022 Dec 9.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
Related trials for Sedentary Behavior
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
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.
Erik Hanson, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One 5-Minute Walking Bout Each Hour, One 15-Minute Standing Bout Each Hour and One 5-Minute Walking Bout and One 15-Minute Standing Bout Each Hour in people with Sedentary Behavior and Sedentary Time, run by University of North Carolina, Chapel Hill 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 11 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 25 Sep 2026. 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?
Mean Change in Carotid-femoral Pulse Wave Velocity (cfPWV) (time frame: Measurements will be taken immediately before and after each 4-hour SB condition). 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 NCT05316571, which also lists 1 linked publication.
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 25 Sep 2026.