Knee OsteoarthristisSTOPPPNCT06976138
Sleep TO Prevent Post-surgical Pain
A study testing Cognitive-Behavioral Therapy for Insomnia, Bright Light therapy via the Re-Timer® and Negative Ion exposure via IonMi Device in people with Knee Osteoarthristis, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This research study is being done to compare different methods of addressing sleep problems before total knee replacement surgery. These methods include Cognitive Behavioral Therapy and light exposure. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Cognitive-Behavioral Therapy for Insomnia, Bright Light therapy via the Re-Timer® and Negative Ion exposure via IonMi Device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jun 2025to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with knee osteoarthritis,
- 60 years old and older,
- scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and
- have trouble falling or staying asleep
Who cannot join
- currently using medications to help sleep
- have completed Cognitive Behavioral Therapy for Insomnia
- used either Bright Light or Negative Ion exposures in the past year
- have an inflammatory rheumatologic disorder, seizure disorder
- serious mental health disorder, Bipolar I disorder, substance or alcohol use disorder
- serious sleep or circadian rhythm disorder, untreated sleep apnea
Show all 12Show fewer
- are pregnant or lactating
- have retinal pathology
- history of eye surgery (Lasik or cataract okay if more than 3 months ago)
- are taking disease-modifying antirheumatic drugs
- taking photosensitizing medications
- are unwilling to discontinue over the counter sleep aids (for example, melatonin) for at least 2 weeks before enrolling
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
Anna Kim-Dahl, 410-550-5704, akimdah1@jhu.edu
Heavon Allen, 4105501000, hallen16@jhmi.edu
- Active, not recruiting
Mass General Brigham
Chestnut Hill, Massachusetts, 02467
About this study
This research study is being done to compare different methods of addressing sleep problems before total knee replacement surgery. These methods include Cognitive Behavioral Therapy and light exposure.
Read the detailed description
This research is being done to evaluate whether combining Cognitive Behavioral Therapy for Insomnia (talk therapy for insomnia) with Morning Bright Light exposure is more effective than Morning Negative Ion exposure combined with either Cognitive Behavioral Therapy for Insomnia or Sleep / Knee Osteoarthritis Education to reduce pain following total knee replacement surgery. This knowledge is needed to develop better ways to manage pain after surgery. Sleep problems are often not treated before or after surgery, so this may differ from the typical care received by adding a focus on sleep. People with knee osteoarthritis, who are 60 years old and older, who are scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and who have trouble falling or staying asleep, may join this study.
There are two possible devices that are being compared in this study.
- If the participants are in the Morning Bright Light exposure group, the participants will use the Re-timer®, a wearable bright light exposure device. This device is commercially available and in use by the general population. This device meets international ultraviolet and blue light hazard safety standards. The light intensities used in this study are greater than most indoor light, but much dimmer than sunlight on a bright day.
- If the participants are in the Negative Ionizer exposure group, the participants will use the IonPacific,"ionMi,"a wearable negative ionizer. This device is also commercially available and in use by the general population.
There have been reports of improved sleep and daytime symptoms associated with poor sleep for both Morning Bright Light and Negative Ionizer exposures. The use of Re-timer and IonMi in this research study is investigational. The word "investigational" means that the Re-timer and IonMi are not approved for marketing by the Food and Drug Administration (FDA).
Participation includes:
A virtual and in person screening and training visit 4, 1-hour long telehealth sessions scheduled each week before surgery 2, 30-minute telehealth sessions, 2-weeks after surgery and 3-months after surgery
This study will be using "blinding" which means only a few members of the study team will know what group / sleep program the participants have been assigned to until the study ends. In case of an emergency, the study doctor can quickly find out which sleep health program the participants have been assigned to receive.
During parts of the study, the device the participants are using may be deactivated in order to test the effects of an active study device compared to a deactivated device. At the end of the study, the team can provide information about the timing of device deactivation.
The participants will not be asked to change the clinical care currently being received for knee osteoarthritis.
- Conditions
- Knee Osteoarthristis
- Being tested
- Cognitive-Behavioral Therapy for Insomnia, Bright Light therapy via the Re-Timer®, Negative Ion exposure via IonMi Device, Sleep / Knee Osteoarthritis Education
- Keywords
- total knee arthroplasty, knee replacement, koa, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy for InsomniaBehavioural
This program will focus on changing the participant's sleep patterns, activities, and habits.
Bright Light therapy via the Re-Timer®Device
Subjects will conduct light treatment in the mornings at home for one hour using Re-timer® The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery
Negative Ion exposure via IonMi DeviceDevice
This procedure involves wearing a light weight negative ionizer (IonMi Device) around neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery
Sleep / Knee Osteoarthritis EducationBehavioural
Also called koa Education
This program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy + Morning Bright Light exposure | Experimental | Cognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits.
Morning Bright Light involves wearing glasses (Re-Timer Device) that give off a special type of bright light for one full hour in the morning. The participant will be asked to wear these glasses every morning for about four weeks before surgery, four weeks after surgery and again for 1-week , 3-months after surgery. The participant will fill out a log to note light on/off times, any interruptions to light treatment, and primary activity while receiving the light exposure. The participant will also receive daily reminders to charge the device and turn it on during the scheduled time. Receives: Behavioral: Cognitive-Behavioral Therapy for Insomnia; Device: Bright Light therapy via the Re-Timer® |
| Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure | Active comparator | Cognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits.
Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. the participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time. Receives: Behavioral: Cognitive-Behavioral Therapy for Insomnia; Device: Negative Ion exposure via IonMi Device |
| Sleep / Knee Osteoarthritis Education + Negative Ion exposure | Active comparator | Sleep / Knee Osteoarthritis Education. This program will focus on increasing the participant's knowledge about sleep, sleep disorders and knee osteoarthritis.
Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time. Receives: Device: Negative Ion exposure via IonMi Device; Behavioral: Sleep / Knee Osteoarthritis Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
Higher scores indicate higher pain. Asked to rate pain in different situations from 0 (no pain) to 10 (extreme pain) on Visual Analog Scale.
Measured: 3 and 6 months post-surgery
Secondary outcomes (5)
Post-surgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Severity
Higher scores indicate higher pain. Asked to rate pain in different situations from 0 (no pain) to 10 (extreme pain) on Visual Analog Scale.
Measured: immediately post surgery, 6 weeks post surgery
Number of participants with Post-surgical opioid use
Opioid use after surgery reported in 7-day virtual diaries. Higher amounts mean higher intake of opioids. Participants will be asked to report prescribed opioids, how often being taken, and provide information via virtual pill count.
Measured: 6-weeks post-surgery, 3 and 6 months post surgery
Insomnia Severity as assessed by the Insomnia Severity Index
Minimum score possible is 0, highest score 28. Higher scores indicate higher insomnia symptoms
Measured: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months
Circadian Rest Activity Rhythm (RAR) assessed by actigraphy
Motion data from actigraphy monitors will be used to estimate circadian rest activities within and across 24-hour intervals. The investigators will model standard circadian RAR parameters derived from actigraphy data using both an extended cosinor analysis as well as non-parametric methods. For example, Pseudo F-statistics, and index of circadian rest activity rhythm, will be derived, and lower Pseudo F-statistics are related to less robust rest activity rhythm strength
Measured: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months
Depressed mood as assessed by the Patient Health Questionnaire (PHQ-9)
Score range of 0-27. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start13 Jun 2025
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled, 3-parallel arm, trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Michael T Smith, PhD, Principal investigator, Johns Hopkins UniversityHelen Burgess, PhD, Principal investigator, University of MichiganRobert R Edwards, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976138
- Sponsor's protocol ID
- IRB00454253
- Other IDs
- 1R01AG085712-01
- Acronym
- STOPPP
- Status last verified
- Aug 2026
- First submitted
- 8 May 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final de-identified, anonymized data sets underlying all publications resulting from the proposed research involving human subjects will be shared with legitimate academic researchers and other community members with a legitimate scientific interest in the research. Where practicable, sharing will take place under a written agreement between the principal investigators prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the data sets. Study documentation (e.g., study protocols) will be made accessible via clinicaltrials.gov and via communication with the principal investigators to facilitate interpretation of the scientific data. Codebooks, other study documentation and deidentified data will be made available on the National Institute on Aging (NIA) National Archive of Computerized Data on Aging data (NACDA) repository.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep TO Prevent Post-surgical Pain
- ClinicalTrials.gov ID
- NCT06976138
- Acronym / sponsor ID
- STOPPP / IRB00454253
- Conditions
- Knee Osteoarthristis
- Keywords
- total knee arthroplasty, knee replacement, koa, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 16 May 2025 (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.
This research study is being done to compare different methods of addressing sleep problems before total knee replacement surgery. These methods include Cognitive Behavioral Therapy and light exposure.
Detailed description
This research is being done to evaluate whether combining Cognitive Behavioral Therapy for Insomnia (talk therapy for insomnia) with Morning Bright Light exposure is more effective than Morning Negative Ion exposure combined with either Cognitive Behavioral Therapy for Insomnia or Sleep / Knee Osteoarthritis Education to reduce pain following total knee replacement surgery. This knowledge is needed to develop better ways to manage pain after surgery. Sleep problems are often not treated before or after surgery, so this may differ from the typical care received by adding a focus on sleep. People with knee osteoarthritis, who are 60 years old and older, who are scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and who have trouble falling or staying asleep, may join this study.
There are two possible devices that are being compared in this study.
- If the participants are in the Morning Bright Light exposure group, the participants will use the Re-timer®, a wearable bright light exposure device. This device is commercially available and in use by the general population. This device meets international ultraviolet and blue light hazard safety standards. The light intensities used in this study are greater than most indoor light, but much dimmer than sunlight on a bright day.
- If the participants are in the Negative Ionizer exposure group, the participants will use the IonPacific,"ionMi,"a wearable negative ionizer. This device is also commercially available and in use by the general population.
There have been reports of improved sleep and daytime symptoms associated with poor sleep for both Morning Bright Light and Negative Ionizer exposures. The use of Re-timer and IonMi in this research study is investigational. The word "investigational" means that the Re-timer and IonMi are not approved for marketing by the Food and Drug Administration (FDA).
Participation includes:
A virtual and in person screening and training visit 4, 1-hour long telehealth sessions scheduled each week before surgery 2, 30-minute telehealth sessions, 2-weeks after surgery and 3-months after surgery
This study will be using "blinding" which means only a few members of the study team will know what group / sleep program the participants have been assigned to until the study ends. In case of an emergency, the study doctor can quickly find out which sleep health program the participants have been assigned to receive.
During parts of the study, the device the participants are using may be deactivated in order to test the effects of an active study device compared to a deactivated device. At the end of the study, the team can provide information about the timing of device deactivation.
The participants will not be asked to change the clinical care currently being received for knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled, 3-parallel arm, trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy + Morning Bright Light exposure | Experimental | Behavioral: Cognitive-Behavioral Therapy for Insomnia, Device: Bright Light therapy via the Re-Timer®Cognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits. Morning Bright Light involves wearing glasses (Re-Timer Device) that give off a special type of bright light for one full hour in the morning. The participant will be asked to wear these glasses every morning for about four weeks before surgery, four weeks after surgery and again for 1-week , 3-months after surgery. The participant will fill out a log to note light on/off times, any interruptions to light treatment, and primary activity while receiving the light exposure. The participant will also receive daily reminders to charge the device and turn it on during the scheduled time. |
| Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure | Active comparator | Behavioral: Cognitive-Behavioral Therapy for Insomnia, Device: Negative Ion exposure via IonMi DeviceCognitive-Behavioral Therapy for Insomnia. This program will focus on changing the participant's sleep patterns, activities, and habits. Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. the participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time. |
| Sleep / Knee Osteoarthritis Education + Negative Ion exposure | Active comparator | Device: Negative Ion exposure via IonMi Device, Behavioral: Sleep / Knee Osteoarthritis EducationSleep / Knee Osteoarthritis Education. This program will focus on increasing the participant's knowledge about sleep, sleep disorders and knee osteoarthritis. Negative Ion exposure. This procedure involves wearing a light weight negative ionizer (IonMi Device) around the neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery The participant will also receive daily reminders to charge the device and turn it on during the scheduled time. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People with knee osteoarthritis,
- 60 years old and older,
- scheduled to have unilateral (one knee) total knee replacement surgery for osteoarthritis and
- have trouble falling or staying asleep
Key exclusion criteria (12 listed)
- currently using medications to help sleep
- have completed Cognitive Behavioral Therapy for Insomnia
- used either Bright Light or Negative Ion exposures in the past year
- have an inflammatory rheumatologic disorder, seizure disorder
- serious mental health disorder, Bipolar I disorder, substance or alcohol use disorder
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-Behavioral Therapy for InsomniaThis program will focus on changing the participant's sleep patterns, activities, and habits. | Behavioural | Cognitive Behavioral Therapy + Morning Bright Light exposure, Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure |
| Bright Light therapy via the Re-Timer®Subjects will conduct light treatment in the mornings at home for one hour using Re-timer® The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery | Device | Cognitive Behavioral Therapy + Morning Bright Light exposure |
| Negative Ion exposure via IonMi DeviceThis procedure involves wearing a light weight negative ionizer (IonMi Device) around neck for one hour in the morning. An ionizer gives off special negatively charged ions into the air. The participant will be asked to wear the device every morning for about four weeks before surgery, four weeks after surgery and again for 1-week, 3-months after surgery | Device | Cognitive Behavioral Therapy for Insomnia + Negative Ion exposure, Sleep / Knee Osteoarthritis Education + Negative Ion exposure |
| Sleep / Knee Osteoarthritis EducationAlso: koa EducationThis program will focus on increasing The participant's knowledge about sleep, sleep disorders and knee osteoarthritis. | Behavioural | Sleep / Knee Osteoarthritis Education + Negative Ion exposure |
Primary outcome
Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 3 and 6 months post-surgery
Higher scores indicate higher pain. Asked to rate pain in different situations from 0 (no pain) to 10 (extreme pain) on Visual Analog Scale.
5 secondary outcomes
Post-surgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Severity
Time frame: immediately post surgery, 6 weeks post surgery
Number of participants with Post-surgical opioid use
Time frame: 6-weeks post-surgery, 3 and 6 months post surgery
Insomnia Severity as assessed by the Insomnia Severity Index
Time frame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months
Circadian Rest Activity Rhythm (RAR) assessed by actigraphy
Time frame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6-months
Depressed mood as assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: pre-surgery, post-surgery 6-weeks, post surgery 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Final de-identified, anonymized data sets underlying all publications resulting from the proposed research involving human subjects will be shared with legitimate academic researchers and other community members with a legitimate scientific interest in the research. Where practicable, sharing will take place under a written agreement between the principal investigators prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the data sets. Study documentation (e.g., study protocols) will be made accessible via clinicaltrials.gov and via communication with the principal investigators to facilitate interpretation of the scientific data. Codebooks, other study documentation and deidentified data will be made available on the National Institute on Aging (NIA) National Archive of Computerized Data on Aging data (NACDA) repository.
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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.
Michael T Smith, PhD principal investigator
Johns Hopkins University
Helen Burgess, PhD principal investigator
University of Michigan
Robert R Edwards, PhD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy for Insomnia, Bright Light therapy via the Re-Timer® and Negative Ion exposure via IonMi Device in people with Knee Osteoarthristis, run by Johns Hopkins University at 2 sites 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Kim-Dahl (410-550-5704, akimdah1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic postsurgical pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (time frame: 3 and 6 months post-surgery). 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 7 Aug 2026.