InsomniaNCT04498754
An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder
A study testing Cognitive Behavior Therapy for Insomnia and Weekly phone contacts in people with Insomnia and Posttraumatic Stress Disorder, run by Duke University at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) is a chronic, debilitating psychiatric disorder that is associated with an increased risk of death due to cardiovascular disease (CVD). Most individuals with PTSD also have Insomnia Disorder. Sleep quality is also associated with risk factors for CVD. Read more about this study
- Who is it for?
- Ages 40 to 59 years
- Conditions the study is for
- Insomnia, Posttraumatic Stress Disorder, Cardiovascular Risk Factor
- What is being tested?
- Cognitive Behavior Therapy for Insomnia and Weekly phone contacts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 9 Mar 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 40 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is between 40-59 years old;
- Has a current diagnosis of chronic PTSD (at least 3 months duration) based on the Clinician Administered PTSD Scale DSM-5 version (Weathers et al., 2013);
- Has a current diagnosis of ID as defined in the International Classification of Sleep Disorders (ICSD-3; American Academy of Sleep Medicine, 2014)
Who cannot join
- Has a history of CVD events, including myocardial infarction, stroke, transient ischemic attack, or coronary revascularization;
- Has diagnosis of congestive heart failure or coronary artery disease based on results of diagnostic testing;
- Has a current alcohol use or substance use disorder (those who meet lifetime but not current alcohol or substance use disorder will be included);
- Is currently participating in or has recently (past 6 months) participated in an evidence-based trauma focused therapy for PTSD;
- Has cognitive impairment as evidenced by less than 20 on the Montreal Cognitive Assessment scale (M0CA; Nasreddine et al., 2005);
- Meets criteria for a psychotic spectrum disorder or bipolar disorder;
Show all 24Show fewer
- Has severely impaired hearing or speech;
- Is pregnant;
- Does not use benzodiazepines for sleep, and if prescribed benzodiazepines for some other use (e.g., anxiety, panic attacks), uses them fewer than four times in a one month period.;
- Is not stable (medications and dose stable for one month) on any other current psychoactive and/or cardiovascular medications or will not be stable on these medications during the course of the study;
- Works night shift;
- Is participating in another interventional study to address insomnia;
- Has prominent suicidal or homicidal ideation (as assessed through a clinical interview);
- Has a serious/terminal illness or other health problem that would prohibit participation in the study;
- Has nonclinically significant or sub-threshold insomnia as indicated by a score of <8 on the Insomnia Severity Index;
- Has seizures (based on clinical interview and self-report);
- Has a body mass index of 45 or greater;
- Has sleep apnea (based on the overnight assessment described below) or a positive sleep apnea screen;
- Has restless leg syndrome (based on the Duke Structured Interview for Sleep Disorders (DSISD); Edinger, Wyatt, \& Olsen, 2009), and that sleep disorder is the primary cause of their sleep complaint (participants with restless legs syndrome who also have insomnia disorder can be included in the study);
- Has an organic cause of sleep disruption that cannot be addressed by cognitive-behavioral changes (e.g., hyperthyroidism), as determined by the DSISD;
- Has excessive daytime sleepiness, defined as a score >15 on the Epworth Sleepiness Scale (ESS) or as determined by the DSISD;
- Does not complete sleep diary assessments within 6 hours of rising on at least 5 of the 7 days of the initial assessment period; or
- Cancels or no-shows for two or more Time 1 assessment appointments
- Has uncontrolled hypertension (screening office BP > 160/100 mm Hg)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27706
About this study
Posttraumatic stress disorder (PTSD) is a chronic, debilitating psychiatric disorder that is associated with an increased risk of death due to cardiovascular disease (CVD). Most individuals with PTSD also have Insomnia Disorder. Sleep quality is also associated with risk factors for CVD. The objective of this study is to examine how insomnia contributes to CVD risk among people with PTSD. The investigators will also examine whether this risk can be decreased with treatment for Insomnia Disorder.
Read the detailed description
Posttraumatic stress disorder (PTSD) is a disabling and costly psychiatric disorder that is estimated to occur in 20% of individuals who are exposed to a traumatic event and is chronic in one third of cases. In addition to its negative impact on quality of life, there is substantial evidence that PTSD (even after controlling for depression and other risk factors) is associated with a markedly increased risk of cardiovascular morbidity and mortality. However, the mechanisms for the association between PTSD and cardiovascular disease (CVD) risk are not well understood. Although adverse health behaviors, including cigarette smoking, alcohol abuse and poor medication adherence are common in PTSD, recent prospective studies show that they do not account for the magnitude of CVD risk among individuals with PTSD. The investigators propose to test our central hypothesis by evaluating whether CBT-I results in improved biomarkers of CVD risk among those with PTSD. Well established biomarkers of CVD related morbidity and mortality will be used including measures of vascular endothelial function measured by brachial artery flow-mediated dilation (FMD), nighttime blood pressure (BP) dipping measured using 24-hour ambulatory blood pressure monitoring (ABPM), and sympathetic nervous system (SNS) activity as measured by 24-hour urinary catecholamines. Investigators will also assess lipid profile, which along with BP is a modifiable component with marked impact on the atherosclerotic cardiovascular disease (ASCVD) risk score. The primary sleep parameter of interest is objectively-measured sleep efficiency (through actigraphy), although self-report insomnia measures and sleep related arousal will also be measured. The rationale for the proposed research is that once it is established that insomnia is an important and modifiable symptom conveying increased CVD risk in this population, the development of new and innovative approaches to integrating insomnia treatment with PTSD-focused interventions can be developed. 150 men and women with comorbid PTSD and insomnia disorder will be randomly assigned with a 2:1 ratio to 8-week cognitive behavioral therapy-Insomnia (CBT-I) intervention or a waiting period control condition. Sleep quality parameters and CVD risk biomarkers will be assessed at pre-randomization baseline, post-intervention, and at a 6-month follow-up. The study is designed to evaluate the association between insomnia and CVD risk biomarkers among persons with PTSD, and determine whether improvements in insomnia symptoms are associated with improvements in CVD risk biomarkers.
- Being tested
- Cognitive Behavior Therapy for Insomnia, Weekly phone contacts
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy for InsomniaBehavioural
Also called CBT-I
8 sessions of treatment for insomnia.
Weekly phone contactsBehavioural
Weekly calls to monitor insomnia symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy for Insomnia (CBT-I) | Experimental | Participants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I). Receives: Behavioral: Cognitive Behavior Therapy for Insomnia |
| Minimal Contact Control Condition | Other | Participants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms. Receives: Behavioral: Weekly phone contacts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nighttime blood pressure
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Measured: Baseline and post-treatment (approximately eight weeks)
Change in nighttime blood pressure
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Measured: Baseline and 6-month follow-up
Change in nighttime blood pressure dipping
Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.
Measured: Baseline and post-treatment (approximately eight weeks)
Change in nighttime blood pressure dipping
Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.
Measured: Baseline and 6-month follow-up
Change in vascular endothelial function
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery. V
Measured: Baseline and post-treatment (approximately eight weeks)
Change in vascular endothelial function
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery.
Measured: Baseline and 6-month follow-up
Change in nighttime sympathetic nervous system activity
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Measured: Baseline and post-treatment (approximately eight weeks)
Change in nighttime sympathetic nervous system activity
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Measured: Baseline and 6-month follow-up
Change in 10-year atherosclerotic cardiovascular disease risk
The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.
Measured: Baseline and post-treatment (approximately eight weeks)
Change in 10-year atherosclerotic cardiovascular disease risk
The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.
Measured: Baseline and 6-month follow-up
Change in insomnia severity
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Measured: Baseline and post-treatment (approximately eight weeks)
Change in insomnia severity
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Measured: Baseline and 6-month follow-up
Change in sleep efficiency
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Measured: Baseline and post-treatment (approximately eight weeks)
Change in sleep efficiency
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Measured: Baseline and 6-month follow-up
Secondary outcomes (4)
Change in subjective sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index. The scale has a score range of 0 to 21, with lower scores on this measure indicating better sleep quality.
Measured: Baseline and 6-month follow-up
Change in subjective sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index.scale has a score range of 0 to 21, with lower scores on this measure indicating better sleep quality.
Measured: Baseline and post-treatment (approximately eight weeks)
Change in quality of life
Quality of life will be measured using the Short Form-36 Health Survey. Scores on this measure range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline and 6-month follow-up
Change in quality of life
Quality of life will be measured using the Short Form-36 Health Survey. Scores on this measure range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline and post-treatment (approximately eight weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start15 Mar 2021
- Primary completion9 Mar 2026
- Study completion9 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who are originally assigned to the minimal contact control condition will be invited to receive the active condition treatment after their study involvement has been completed, but no additional data will be collected from them.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean C Beckham, PhD, Principal investigator, Duke HealthAndrew Sherwood, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498754
- Sponsor's protocol ID
- PRO00100446
- Status last verified
- Mar 2026
- First submitted
- 30 Jul 2020
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04498754
- Acronym / sponsor ID
- PRO00100446
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 4 Aug 2020 (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.
Posttraumatic stress disorder (PTSD) is a chronic, debilitating psychiatric disorder that is associated with an increased risk of death due to cardiovascular disease (CVD). Most individuals with PTSD also have Insomnia Disorder. Sleep quality is also associated with risk factors for CVD. The objective of this study is to examine how insomnia contributes to CVD risk among people with PTSD. The investigators will also examine whether this risk can be decreased with treatment for Insomnia Disorder.
Detailed description
Posttraumatic stress disorder (PTSD) is a disabling and costly psychiatric disorder that is estimated to occur in 20% of individuals who are exposed to a traumatic event and is chronic in one third of cases. In addition to its negative impact on quality of life, there is substantial evidence that PTSD (even after controlling for depression and other risk factors) is associated with a markedly increased risk of cardiovascular morbidity and mortality. However, the mechanisms for the association between PTSD and cardiovascular disease (CVD) risk are not well understood. Although adverse health behaviors, including cigarette smoking, alcohol abuse and poor medication adherence are common in PTSD, recent prospective studies show that they do not account for the magnitude of CVD risk among individuals with PTSD. The investigators propose to test our central hypothesis by evaluating whether CBT-I results in improved biomarkers of CVD risk among those with PTSD. Well established biomarkers of CVD related morbidity and mortality will be used including measures of vascular endothelial function measured by brachial artery flow-mediated dilation (FMD), nighttime blood pressure (BP) dipping measured using 24-hour ambulatory blood pressure monitoring (ABPM), and sympathetic nervous system (SNS) activity as measured by 24-hour urinary catecholamines. Investigators will also assess lipid profile, which along with BP is a modifiable component with marked impact on the atherosclerotic cardiovascular disease (ASCVD) risk score. The primary sleep parameter of interest is objectively-measured sleep efficiency (through actigraphy), although self-report insomnia measures and sleep related arousal will also be measured. The rationale for the proposed research is that once it is established that insomnia is an important and modifiable symptom conveying increased CVD risk in this population, the development of new and innovative approaches to integrating insomnia treatment with PTSD-focused interventions can be developed. 150 men and women with comorbid PTSD and insomnia disorder will be randomly assigned with a 2:1 ratio to 8-week cognitive behavioral therapy-Insomnia (CBT-I) intervention or a waiting period control condition. Sleep quality parameters and CVD risk biomarkers will be assessed at pre-randomization baseline, post-intervention, and at a 6-month follow-up. The study is designed to evaluate the association between insomnia and CVD risk biomarkers among persons with PTSD, and determine whether improvements in insomnia symptoms are associated with improvements in CVD risk biomarkers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who are originally assigned to the minimal contact control condition will be invited to receive the active condition treatment after their study involvement has been completed, but no additional data will be collected from them.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy for Insomnia (CBT-I) | Experimental | Behavioral: Cognitive Behavior Therapy for InsomniaParticipants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I). |
| Minimal Contact Control Condition | Other | Behavioral: Weekly phone contactsParticipants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is between 40-59 years old;
- Has a current diagnosis of chronic PTSD (at least 3 months duration) based on the Clinician Administered PTSD Scale DSM-5 version (Weathers et al., 2013);
- Has a current diagnosis of ID as defined in the International Classification of Sleep Disorders (ICSD-3; American Academy of Sleep Medicine, 2014)
Key exclusion criteria (24 listed)
- Has a history of CVD events, including myocardial infarction, stroke, transient ischemic attack, or coronary revascularization;
- Has diagnosis of congestive heart failure or coronary artery disease based on results of diagnostic testing;
- Has a current alcohol use or substance use disorder (those who meet lifetime but not current alcohol or substance use disorder will be included);
- Is currently participating in or has recently (past 6 months) participated in an evidence-based trauma focused therapy for PTSD;
- Has cognitive impairment as evidenced by less than 20 on the Montreal Cognitive Assessment scale (M0CA; Nasreddine et al., 2005);
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 |
|---|---|---|
| Cognitive Behavior Therapy for InsomniaAlso: CBT-I8 sessions of treatment for insomnia. | Behavioural | Cognitive Behavior Therapy for Insomnia (CBT-I) |
| Weekly phone contactsWeekly calls to monitor insomnia symptoms. | Behavioural | Minimal Contact Control Condition |
Primary outcome
Change in nighttime blood pressure
Time frame: Baseline and post-treatment (approximately eight weeks)
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Change in nighttime blood pressure
Time frame: Baseline and 6-month follow-up
Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.
Change in nighttime blood pressure dipping
Time frame: Baseline and post-treatment (approximately eight weeks)
Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.
Change in nighttime blood pressure dipping
Time frame: Baseline and 6-month follow-up
Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.
Change in vascular endothelial function
Time frame: Baseline and post-treatment (approximately eight weeks)
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery. V
Change in vascular endothelial function
Time frame: Baseline and 6-month follow-up
Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery.
Change in nighttime sympathetic nervous system activity
Time frame: Baseline and post-treatment (approximately eight weeks)
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Change in nighttime sympathetic nervous system activity
Time frame: Baseline and 6-month follow-up
Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.
Change in 10-year atherosclerotic cardiovascular disease risk
Time frame: Baseline and post-treatment (approximately eight weeks)
The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.
Change in 10-year atherosclerotic cardiovascular disease risk
Time frame: Baseline and 6-month follow-up
The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.
Change in insomnia severity
Time frame: Baseline and post-treatment (approximately eight weeks)
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Change in insomnia severity
Time frame: Baseline and 6-month follow-up
Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.
Change in sleep efficiency
Time frame: Baseline and post-treatment (approximately eight weeks)
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
Change in sleep efficiency
Time frame: Baseline and 6-month follow-up
Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.
4 secondary outcomes
Change in subjective sleep quality
Time frame: Baseline and 6-month follow-up
Change in subjective sleep quality
Time frame: Baseline and post-treatment (approximately eight weeks)
Change in quality of life
Time frame: Baseline and 6-month follow-up
Change in quality of life
Time frame: Baseline and post-treatment (approximately eight weeks)
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 16 Mar 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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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.
Jean C Beckham, PhD principal investigator
Duke Health
Andrew Sherwood, PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy for Insomnia and Weekly phone contacts in people with Insomnia and Posttraumatic Stress Disorder, run by Duke 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 3 inclusion and 24 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 16 Mar 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?
Change in nighttime blood pressure (time frame: Baseline and post-treatment (approximately eight weeks)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.