HIV-1NCT04956861

HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction

A study testing Individualized Targeted Sleep in people with HIV-1, run by University of Colorado, Boulder at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 75 years
Conditions the study is for: HIV-1
What is being tested?: Individualized Targeted Sleep
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteUnited States
Study dates: 17 Dec 2015to 7 Aug 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects will be men and women of all races and ethnic backgrounds aged 40-75 years with documented HIV-1 infection.
Subjects will be HIV-1-seropositive individuals on a stable DHHS approved ART regimen for at least 6 months, with documented virologic suppression (<50 copies HIV-1 RNA/mL) for at least 3 months.
All subjects must have CD4+ T cell counts >200 cells/mm3 at the time of study entry.
Subjects will be free of overt CVD as assessed by: a) medical history; b) physical examination; c) electrocardiogram and BP at rest and maximal exercise; d) complete blood chemistries, lipid and lipoprotein, glucose, insulin and hematological evaluation.
All candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 6 months prior to the study.

Who cannot join

Receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
Pre- or peri-menopausal women

Trial locations and contacts

1 site in 1 country.

United States1 site

UC-Boulder Clinical and Translational Research Center
Boulder, Colorado, 80309

Other trials in United States

About this study

The investigators hypothesize that chronic insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and tissue-type plasminogen activator release in anti-retroviral (ART)-treated HIV-1-seropositive adults. Furthermore, the investigators hypothesize that the postulated diminishment in endothelial vasodilator and fibrinolytic function with insufficient sleep will be due, at least in part, to increased oxidative stress. Moreover, increasing sleep duration and improving sleep quality will increase both endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in ART-treated HIV-1-seropositive adults. Increases in endothelial vasodilator and fibrinolytic function will be due, at least in part, to reduced oxidative stress.

Conditions: HIV-1
Being tested: Individualized Targeted Sleep
Keywords: Sleep

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Individualized Targeted SleepBehavioural
The investigators will employ an 8-week individualized targeted sleep intervention. Individualized targeted interventions have the advantage of improving adherence, reducing attrition, and making the strategy personally meaningful.

Study groups in NCT04956861
Study group	Role	What they receive
Phase 1	No intervention	Phase 1 is a cross-sectional study to compare endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).
Phase 2	Experimental	Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night. Receives: Behavioral: Individualized Targeted Sleep

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh)
FBF was measured via strain-gauge venous occlusion plethysmography in response to saline for 5 minutes and then to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min; the doses of Acetylcholine infused into the brachial artery) for 5 minutes at each dose. Flows during the last minute of saline and each drug dose were measured and the mean value reported.
Values after saline and after ACh 4.0, 8.0 and 16.0 at week 3 are reported.
Measured: FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 2: FBF Response to Acetylcholine (ACh)
FBF to ACh will be measured following the participants 8 week sleep intervention.
Measured: FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)
Measured: FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)
FBF to NTP will me measured following the participants 8 week sleep intervention
Measured: FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Phase 1: Endothelial Tissue Type Plasminogen Activator (t-PA) Release in Response to Bradykinin (BDK)
Net endothelial release of t-PA antigen in response to BDK was calculated using the following equation:
Net release = (Cv-Ca) x (FBF x [101-hematocrit/100]) where Cv and Ca represent the concentration in the vein and artery respectively. A positive difference indicated a net release and a negative difference, net uptake. Arterial and venous blood samples were collected simultaneously at the end of saline and each dose of BDK (12.5, 25.0 and 50.0 ng/100mL tissue/min). Enzyme immunoassay was used to determine t-PA antigen concentrations. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the red blood cells.
Measured: t-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 2: Endothelial t-PA Release in Response to Bradykinin (BDK)
Endothelial t-PA release will me measured following the participants 8 week sleep intervention. Net endothelial release of t-PA antigen in response to BDK was calculated using the following equation:
Net release = (Cv-Ca) x (FBF x [101-hematocrit/100]) where Cv and Ca represent the concentration in the vein and artery respectively. A positive difference indicated a net release and a negative difference, net uptake. Arterial and venous blood samples were collected simultaneously at the end of saline and each dose of BDK (12.5, 25.0 and 50.0 ng/100mL tissue/min). Enzyme immunoassay was used to determine t-PA antigen concentrations. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the red blood cells.
Measured: t-PA release will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Phase 1: FBF Response to ACh+Ng-monomethyl-L-arginine (L-NMMA)
To determine the contribution of nitric oxide to ACh-mediated vasodilation, FBF to ACh was quantified before and after infusion of L-NMMA. After ACh was infused as described in Outcome measure 1 the ACh dose response was repeated with the continuous infusion of L-NMMA.
Measured: FBF response to ACh+L-NMMA will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 1: FBF Response to ACh+Vitamin C
After allowing sufficient time (45 minutes) for FBF to return to levels similar to that of saline Vitamin C was infused at a constant rate (12 mg/100 mL tissue/min) for 5 minutes. This vitamin C concentration has been show to improve endothelium dependent vasodilation in conditions associated with oxidative stress. Vitamin C infusion was maintained at the same rate while the ACh dose response was repeated.
Measured: FBF response to ACh+Vitamin C will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 2: FBF Response to ACh+L-NMMA
FBF to ACh+L-NMMA will me measured following the participants 8 week sleep intervention. To determine the contribution of nitric oxide to ACh-mediated vasodilation, FBF to ACh was quantified before and after infusion of L-NMMA. After ACh was infused as described in Outcome measure 1 the ACh dose response was repeated with the continuous infusion of L-NMMA.
Measured: FBF response to ACh+L-NMMA will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Phase 2: FBF Response to ACh+Vitamin C
FBF to ACh+Vitamin C will me measured following the participants 8 week sleep intervention. After allowing sufficient time (45 minutes) for FBF to return to levels similar to that of saline Vitamin C was infused at a constant rate (12 mg/100 mL tissue/min) for 5 minutes. This vitamin C concentration has been show to improve endothelium dependent vasodilation in conditions associated with oxidative stress. Vitamin C infusion was maintained at the same rate while the ACh dose response was repeated.
Measured: FBF response to ACh+Vitamin C will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date

Secondary outcomes (1)

Nightly Sleep Duration
Nightly sleep duration was calculated as the weighted average of weeknights and weekend values [(5 x weekday sleep duration)+(2 x weekend sleep duration)/7].
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 20157 Aug 2020

First posted9 Jul 2021
Study start17 Dec 2015
Primary completion7 Aug 2020
Study completion7 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-1Studies 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: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04956861
Sponsor's protocol ID: 150465
Status last verified: Dec 2024
First submitted: 23 Jun 2021
Last updated: 23 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1 trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
ClinicalTrials.gov ID: NCT04956861
Acronym / sponsor ID: 150465
Conditions: HIV-1
Keywords: Sleep
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: University of Colorado, BoulderUniversity, hospital or other
Study start: 17 Dec 2015 (actual)
Primary completion: 7 Aug 2020 (actual)
Study completion: 7 Aug 2020 (actual)
First posted: 9 Jul 2021 (actual)
Results: Posted 23 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase 1	No intervention	–Phase 1 is a cross-sectional study to compare endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).
Phase 2	Experimental	Behavioral: Individualized Targeted SleepPhase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects will be men and women of all races and ethnic backgrounds aged 40-75 years with documented HIV-1 infection.
Subjects will be HIV-1-seropositive individuals on a stable DHHS approved ART regimen for at least 6 months, with documented virologic suppression (<50 copies HIV-1 RNA/mL) for at least 3 months.
All subjects must have CD4+ T cell counts >200 cells/mm3 at the time of study entry.
Subjects will be free of overt CVD as assessed by: a) medical history; b) physical examination; c) electrocardiogram and BP at rest and maximal exercise; d) complete blood chemistries, lipid and lipoprotein, glucose, insulin and hematological evaluation.
All candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 6 months prior to the study.

Key exclusion criteria (2 listed)

Receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
Pre- or peri-menopausal women

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
Individualized Targeted SleepThe investigators will employ an 8-week individualized targeted sleep intervention. Individualized targeted interventions have the advantage of improving adherence, reducing attrition, and making the strategy personally meaningful.	Behavioural	Phase 2

Primary outcome

Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh)
Time frame: FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
FBF was measured via strain-gauge venous occlusion plethysmography in response to saline for 5 minutes and then to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min; the doses of Acetylcholine infused into the brachial artery) for 5 minutes at each dose. Flows during the last minute of saline and each drug dose were measured and the mean value reported. Values after saline and after ACh 4.0, 8.0 and 16.0 at week 3 are reported.
Phase 2: FBF Response to Acetylcholine (ACh)
Time frame: FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
FBF to ACh will be measured following the participants 8 week sleep intervention.
Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)
Time frame: FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)
Time frame: FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
FBF to NTP will me measured following the participants 8 week sleep intervention
Phase 1: Endothelial Tissue Type Plasminogen Activator (t-PA) Release in Response to Bradykinin (BDK)
Time frame: t-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Net endothelial release of t-PA antigen in response to BDK was calculated using the following equation: Net release = (Cv-Ca) x (FBF x [101-hematocrit/100]) where Cv and Ca represent the concentration in the vein and artery respectively. A positive difference indicated a net release and a negative difference, net uptake. Arterial and venous blood samples were collected simultaneously at the end of saline and each dose of BDK (12.5, 25.0 and 50.0 ng/100mL tissue/min). Enzyme immunoassay was used to determine t-PA antigen concentrations. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the red blood cells.
Phase 2: Endothelial t-PA Release in Response to Bradykinin (BDK)
Time frame: t-PA release will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Endothelial t-PA release will me measured following the participants 8 week sleep intervention. Net endothelial release of t-PA antigen in response to BDK was calculated using the following equation: Net release = (Cv-Ca) x (FBF x [101-hematocrit/100]) where Cv and Ca represent the concentration in the vein and artery respectively. A positive difference indicated a net release and a negative difference, net uptake. Arterial and venous blood samples were collected simultaneously at the end of saline and each dose of BDK (12.5, 25.0 and 50.0 ng/100mL tissue/min). Enzyme immunoassay was used to determine t-PA antigen concentrations. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the red blood cells.
Phase 1: FBF Response to ACh+Ng-monomethyl-L-arginine (L-NMMA)
Time frame: FBF response to ACh+L-NMMA will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
To determine the contribution of nitric oxide to ACh-mediated vasodilation, FBF to ACh was quantified before and after infusion of L-NMMA. After ACh was infused as described in Outcome measure 1 the ACh dose response was repeated with the continuous infusion of L-NMMA.
Phase 1: FBF Response to ACh+Vitamin C
Time frame: FBF response to ACh+Vitamin C will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
After allowing sufficient time (45 minutes) for FBF to return to levels similar to that of saline Vitamin C was infused at a constant rate (12 mg/100 mL tissue/min) for 5 minutes. This vitamin C concentration has been show to improve endothelium dependent vasodilation in conditions associated with oxidative stress. Vitamin C infusion was maintained at the same rate while the ACh dose response was repeated.
Phase 2: FBF Response to ACh+L-NMMA
Time frame: FBF response to ACh+L-NMMA will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
FBF to ACh+L-NMMA will me measured following the participants 8 week sleep intervention. To determine the contribution of nitric oxide to ACh-mediated vasodilation, FBF to ACh was quantified before and after infusion of L-NMMA. After ACh was infused as described in Outcome measure 1 the ACh dose response was repeated with the continuous infusion of L-NMMA.
Phase 2: FBF Response to ACh+Vitamin C
Time frame: FBF response to ACh+Vitamin C will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
FBF to ACh+Vitamin C will me measured following the participants 8 week sleep intervention. After allowing sufficient time (45 minutes) for FBF to return to levels similar to that of saline Vitamin C was infused at a constant rate (12 mg/100 mL tissue/min) for 5 minutes. This vitamin C concentration has been show to improve endothelium dependent vasodilation in conditions associated with oxidative stress. Vitamin C infusion was maintained at the same rate while the ACh dose response was repeated.

1 secondary outcome

Nightly Sleep Duration
Time frame: Baseline

Results and safety

Results posted to the registry on 23 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Intervention: Phase 1 Normal Sleep Group	36	28
No Intervention: Phase 1 Short Sleep Group	42	33
Experimental: Phase 2	10	7

Primary outcome: Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh)

Time frame: FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.. Mean (Standard Error). Unit: mL/100 mL tissue/min

Measure	Normal Sleep Duration n = 18	Short Sleep Duration n = 22
Saline	4.6 (0.3)	4.2 (0.3)
ACh 4.0	11.7 (0.8)	9.9 (0.5)
ACh 8.0	12.4 (0.8)	10.5 (0.6)
ACh 16.0	14.1 (0.7)	12.0 (0.6)

Population analysed: The number or participants analyzed is different than the participant flow module as these are the participants who completed visit 3.

Primary outcome: Phase 2: FBF Response to Acetylcholine (ACh)

Time frame: FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date. Mean (Standard Error). Unit: mL/100 mL tissue/min

Measure	Phase 2 Before Sleep Intervention n = 7	Phase 2 After Sleep Intervention n = 7
Saline	4.2 (0.4)	4.0 (0.3)
ACh 4.0	9.2 (0.8)	11.1 (0.7)
Ach 8.0	9.9 (0.9)	12.2 (0.7)
Ach 16.0	11.3 (0.9)	14.0 (0.6)

Primary outcome: Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)

Time frame: FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.. Mean (Standard Error). Unit: mL/100 mL tissue/min

Measure	Normal Sleep Duration n = 18	Short Sleep Duration n = 22
Saline	4.8 (0.4)	4.0 (0.3)
NTP 1.0	13.9 (0.9)	12.4 (0.8)
NTP 2.0	16.1 (1.0)	14.5 (0.7)
NTP 4.0	17.0 (1.1)	16.7 (0.8)

Population analysed: The number or participants analyzed is different than the participant flow module due to availability of Sodium Nitroprusside.

Primary outcome: Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)

Time frame: FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date. Mean (Standard Error). Unit: mL/100 mL tissue/min

Measure	Phase 2 Before Sleep Intervention n = 7	Phase 2 After Sleep Intervention n = 7
Saline	3.6 (0.4)	4.2 (0.6)
NTP 1.0	12.0 (0.9)	13.8 (1.1)
NTP 2.0	13.9 (0.9)	14.6 (1.2)
NTP 4.0	15.7 (1.1)	15.7 (1.4)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data was collected for participants while they were enrolled in the study. Each participant was in the study for a maximum of 4 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Cross-sectional Study	0 of 78 (0%)	0 of 78 (0%)	0 of 78
Phase 2: Intervention Study	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Christopher DeSouza, PhD principal investigator

University of Colorado, Boulder

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Individualized Targeted Sleep in people with HIV-1, run by University of Colorado, Boulder 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 2 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 23 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh) (time frame: FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.). The study lists 10 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 NCT04956861.

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 23 Jan 2025.