SleepNCT06602960
Nextsense Brain-sensing Buds Study
A study testing Accurate Sleep Data Feedback, Inflated Sleep Data Feedback and Deflated Sleep Data Feedback in people with Sleep and Sleep Quality, run by NextSense, Inc. at 1 site in United States.
Trial summary
The purpose of this clinical trial is to explore how the presentation of sleep data impacts sleep quality, sleep-related behaviors (such as sleepiness), and sleep-related anxiety and stress. The study aims to answer the following key questions: 1. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Quality, Sleepiness, Daytime
- What is being tested?
- Accurate Sleep Data Feedback, Inflated Sleep Data Feedback and Deflated Sleep Data Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 15 Apr 2025
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants have the capacity to understand the informed consent for study participation and ability for subject to comply with the requirements of the study
- Experiencing mild to moderate sleep disturbances, but without sleep disorder diagnosis
- Naïve to sleep tracker use
- Age 25-65
Who cannot join
- Participants who have used any type of sleep tracker, such as Oura, Fitbit, Google Fit, Garmin Connect, or Apple Watch Sleep
- Health conditions (i.e., cancer, cognitive impairment, panic disorder, post-traumatic stress disorder, sleep apnea, insomnia, restless leg syndrome, Parkinson's disease)
- Use of Modafinil (Provigil), Methylphenidate (Ritalin), Sodium oxybate (Xyrem), Melatonin, Benadryl, Wakix, Sunosi or prescription medications for ADHD Enrollment in other sleep studies
- Women who are pregnant or who are currently nursing/breastfeeding will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alethios (Virtual Study Platform)
San Francisco, California, 94109
About this study
The purpose of this clinical trial is to explore how the presentation of sleep data impacts sleep quality, sleep-related behaviors (such as sleepiness), and sleep-related anxiety and stress. The study aims to answer the following key questions:
- Does receiving sleep-related feedback from a wearable sleep tracker affect an individual\'s mindset about sleep?
- How does the mindset about sleep influence sleep quality, sleepiness, and stress/anxiety levels related to sleep?
- Does the feedback on sleep data moderate the relationship between one\'s mindset about sleep and their sleep quality?
Read more
Participants will:
- Be randomly assigned to receive different types of feedback about their sleep data to determine if the way sleep data is presented influences self-reported sleep quality, sleepiness, and sleep-related stress.
- During the baseline period (Weeks 1-2), complete daily and weekly surveys assessing their sleep habits, beliefs about sleep, anxiety, stress, and mindset regarding sleep.
- For Weeks 3-4, wear a Fitbit and Brain-Sensing earbuds, receiving daily feedback on their sleep.
- At the end of the study, provide feedback on their experience using the devices. Participants may choose to return the devices or keep them after the study concludes.
Read the detailed description
With the growing prevalence of sleep-tracking wearables available to consumers, understanding the psychological and behavioral impacts they have on users is important. Recent advancements in wearable technology allow for monitoring various sleep parameters, providing users with extensive data on their sleep patterns. The study aims to examine how the presentation of sleep data influences user sleep quality, sleep-related behaviors, including sleepiness, and sleep-related anxiety and stress. It will evaluate how the presentation of sleep data affects individuals\' perceptions of sleep and related health issues, including daytime sleepiness and perceived sleep quality. Participants will receive sleep data feedback based on new methods assessed using Fitbit, brain-sensing earbuds, and other factors that might impact sleep. Additionally, the study seeks to offer valuable insights into sleep research, behavioral psychology, and wearable technology.
- Conditions
- Sleep, Sleep Quality, Sleepiness, Daytime, Technology
- Being tested
- Accurate Sleep Data Feedback, Inflated Sleep Data Feedback, Deflated Sleep Data Feedback, Accurate Sleep Data Feedback + Sleep-related Educational Information
- Keywords
- sleep, mindset about sleep, brain-sensing buds
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accurate Sleep Data FeedbackBehavioural
Participants will receive accurate feedback about their sleep data.
Inflated Sleep Data FeedbackBehavioural
Participants will receive inflated feedback about their sleep data, suggesting better sleep quality than detected by Fitbit (actual sleep hours +10%).
Deflated Sleep Data FeedbackBehavioural
Participants will receive deflated feedback about their sleep data, suggesting poorer sleep quality than detected by Fitbit (actual sleep hours -10%).
Accurate Sleep Data Feedback + Sleep-related Educational InformationBehavioural
Participants will receive accurate feedback about their sleep data along with sleep-related educational information.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey.
In this arm, participants will receive accurate feedback about their sleep data. Receives: Behavioral: Accurate Sleep Data Feedback |
| Intervention Group 1 | Experimental | All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey.
In this arm, participants will receive inflated feedback about their sleep data, suggesting better sleep quality than detected by Fitbit (actual sleep hours +10%). Receives: Behavioral: Inflated Sleep Data Feedback |
| Intervention Group 2 | Experimental | All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey.
In this arm, participants will receive deflated feedback about their sleep data, suggesting poorer sleep quality than detected by Fitbit (actual sleep hours -10%). Receives: Behavioral: Deflated Sleep Data Feedback |
| Intervention Group 3 | Experimental | All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey.
In this arm, participants will receive accurate feedback about their sleep data along with sleep-related educational information. Receives: Behavioral: Accurate Sleep Data Feedback + Sleep-related Educational Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant-reported Sleep Quality
Measured via self-report using the 15-item Groningen Sleep Quality Scale, with scores ranging from 1 to 14. A score of 14 indicates poor sleep quality the previous night.
Measured: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Sleep data - Total hours of sleep
Total hours of sleep data tracked by Fitbit
Measured: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Modified Karolinska Sleepiness Scale
Sleepiness, measured via self-report using the 1-item modified Karolinska Sleepiness Scale, ranges from 1 to 10, with 1 indicating extreme alertness, 3 alert, 5 neither alert nor sleepy, 7 sleepy but no difficulty remaining awake, 9 extremely sleepy, fighting sleep, and 10 extremely sleepy, falling asleep all the time.
Measured: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Fitbit tracked Sleep Quality
Fitbit sleep score, ranging from 0 to 100, indicates sleep quality: 90-100 is excellent, 80-89 good, 60-79 fair, and 0-59 poor, based on duration, disturbances, and restorative sleep.
Measured: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Secondary outcomes (6)
Anxiety, Stress, and Mindset related to Sleep
Measured via self-report using the 7-item survey.
Measured: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Dysfunctional Beliefs and Attitudes about Sleep 16-item
Sleep-related mindset, measured via self-report using the 16-item Dysfunctional Beliefs and Attitudes about Sleep, involves calculating the average of the scores from all 16 items. Higher average scores indicate a stronger endorsement of sleep-disruptive beliefs, which are considered maladaptive.
Measured: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Modified Insomnia Severity Index
Severity of Sleep Problems, measured via self-report using the 5-item Insomnia Severity Index, modified to replace Insomnia with Sleep.
Measured: Week 2 and Week 4: measured twice.
Satisfaction with sleep
Measured via self-report using a single item, with scores ranging from 1 to 5, where 1 indicates very satisfied and 5 indicates very dissatisfied.
Measured: Week 2 and Week 4: measured twice.
Sleep Problems Interference with Daily Functioning
Measured via self-report using a single item, with scores ranging from 1 to 5, where 1 indicates not at all interfering and 5 indicates very much interfering.
Measured: Week 2 and Week 4: measured twice.
Pre-Sleep Arousal Scale
Pre-sleep arousal, measured via self-report using the 16-item Pre-Sleep Arousal Scale, with items rated on a 5-point Likert scale from 1 (not at all) to 5 (extremely). The sum of scores from the first 8 items reflects somatic pre-sleep arousal, and the sum of scores from the last 8 items reflects cognitive pre-sleep arousal. Clinically relevant cut-off scores will be used: ≥14 for somatic pre-sleep arousal and ≥20 for cognitive pre-sleep arousal.
Measured: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Oct 2024
- Primary completion5 Feb 2025
- Study completion15 Apr 2025
Why it stopped: The study was stopped due to technical difficulties in verifying participants' receipt of the intervention-specifically, whether they opened the intervention message.We completed a preliminary analysis of data from 40 participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NextSense, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung Mi Kim, PhD, Principal investigator, MandK Consulting PartnersMichele D Nelson, PhD, Principal investigator, MandK Consulting Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602960
- Sponsor's protocol ID
- Sterling IRB #12205
- Status last verified
- Apr 2025
- First submitted
- 16 Sep 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nextsense Brain-sensing Buds Study
- ClinicalTrials.gov ID
- NCT06602960
- Acronym / sponsor ID
- Sterling IRB #12205
- Conditions
- Sleep, Sleep Quality, Sleepiness, Daytime, Technology
- Keywords
- sleep, mindset about sleep, brain-sensing buds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to technical difficulties in verifying participants' receipt of the intervention-specifically, whether they opened the intervention message.We completed a preliminary analysis of data from 40 participants.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NextSense, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to explore how the presentation of sleep data impacts sleep quality, sleep-related behaviors (such as sleepiness), and sleep-related anxiety and stress. The study aims to answer the following key questions:
- Does receiving sleep-related feedback from a wearable sleep tracker affect an individual\'s mindset about sleep?
- How does the mindset about sleep influence sleep quality, sleepiness, and stress/anxiety levels related to sleep?
- Does the feedback on sleep data moderate the relationship between one\'s mindset about sleep and their sleep quality?
Participants will:
- Be randomly assigned to receive different types of feedback about their sleep data to determine if the way sleep data is presented influences self-reported sleep quality, sleepiness, and sleep-related stress.
- During the baseline period (Weeks 1-2), complete daily and weekly surveys assessing their sleep habits, beliefs about sleep, anxiety, stress, and mindset regarding sleep.
- For Weeks 3-4, wear a Fitbit and Brain-Sensing earbuds, receiving daily feedback on their sleep.
- At the end of the study, provide feedback on their experience using the devices. Participants may choose to return the devices or keep them after the study concludes.
Detailed description
With the growing prevalence of sleep-tracking wearables available to consumers, understanding the psychological and behavioral impacts they have on users is important. Recent advancements in wearable technology allow for monitoring various sleep parameters, providing users with extensive data on their sleep patterns. The study aims to examine how the presentation of sleep data influences user sleep quality, sleep-related behaviors, including sleepiness, and sleep-related anxiety and stress. It will evaluate how the presentation of sleep data affects individuals\' perceptions of sleep and related health issues, including daytime sleepiness and perceived sleep quality. Participants will receive sleep data feedback based on new methods assessed using Fitbit, brain-sensing earbuds, and other factors that might impact sleep. Additionally, the study seeks to offer valuable insights into sleep research, behavioral psychology, and wearable technology.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Accurate Sleep Data FeedbackAll arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive accurate feedback about their sleep data. |
| Intervention Group 1 | Experimental | Behavioral: Inflated Sleep Data FeedbackAll arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive inflated feedback about their sleep data, suggesting better sleep quality than detected by Fitbit (actual sleep hours +10%). |
| Intervention Group 2 | Experimental | Behavioral: Deflated Sleep Data FeedbackAll arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive deflated feedback about their sleep data, suggesting poorer sleep quality than detected by Fitbit (actual sleep hours -10%). |
| Intervention Group 3 | Experimental | Behavioral: Accurate Sleep Data Feedback + Sleep-related Educational InformationAll arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive accurate feedback about their sleep data along with sleep-related educational information. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All participants have the capacity to understand the informed consent for study participation and ability for subject to comply with the requirements of the study
- Experiencing mild to moderate sleep disturbances, but without sleep disorder diagnosis
- Naïve to sleep tracker use
- Age 25-65
Key exclusion criteria (4 listed)
- Participants who have used any type of sleep tracker, such as Oura, Fitbit, Google Fit, Garmin Connect, or Apple Watch Sleep
- Health conditions (i.e., cancer, cognitive impairment, panic disorder, post-traumatic stress disorder, sleep apnea, insomnia, restless leg syndrome, Parkinson's disease)
- Use of Modafinil (Provigil), Methylphenidate (Ritalin), Sodium oxybate (Xyrem), Melatonin, Benadryl, Wakix, Sunosi or prescription medications for ADHD Enrollment in other sleep studies
- Women who are pregnant or who are currently nursing/breastfeeding will be excluded from this study.
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 |
|---|---|---|
| Accurate Sleep Data FeedbackParticipants will receive accurate feedback about their sleep data. | Behavioural | Control Group |
| Inflated Sleep Data FeedbackParticipants will receive inflated feedback about their sleep data, suggesting better sleep quality than detected by Fitbit (actual sleep hours +10%). | Behavioural | Intervention Group 1 |
| Deflated Sleep Data FeedbackParticipants will receive deflated feedback about their sleep data, suggesting poorer sleep quality than detected by Fitbit (actual sleep hours -10%). | Behavioural | Intervention Group 2 |
| Accurate Sleep Data Feedback + Sleep-related Educational InformationParticipants will receive accurate feedback about their sleep data along with sleep-related educational information. | Behavioural | Intervention Group 3 |
Primary outcome
Participant-reported Sleep Quality
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Measured via self-report using the 15-item Groningen Sleep Quality Scale, with scores ranging from 1 to 14. A score of 14 indicates poor sleep quality the previous night.
Sleep data - Total hours of sleep
Time frame: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Total hours of sleep data tracked by Fitbit
Modified Karolinska Sleepiness Scale
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Sleepiness, measured via self-report using the 1-item modified Karolinska Sleepiness Scale, ranges from 1 to 10, with 1 indicating extreme alertness, 3 alert, 5 neither alert nor sleepy, 7 sleepy but no difficulty remaining awake, 9 extremely sleepy, fighting sleep, and 10 extremely sleepy, falling asleep all the time.
Fitbit tracked Sleep Quality
Time frame: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Fitbit sleep score, ranging from 0 to 100, indicates sleep quality: 90-100 is excellent, 80-89 good, 60-79 fair, and 0-59 poor, based on duration, disturbances, and restorative sleep.
6 secondary outcomes
Anxiety, Stress, and Mindset related to Sleep
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Dysfunctional Beliefs and Attitudes about Sleep 16-item
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Modified Insomnia Severity Index
Time frame: Week 2 and Week 4: measured twice.
Satisfaction with sleep
Time frame: Week 2 and Week 4: measured twice.
Sleep Problems Interference with Daily Functioning
Time frame: Week 2 and Week 4: measured twice.
Pre-Sleep Arousal Scale
Time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Results and safety
The study was stopped early (reason given: The study was stopped due to technical difficulties in verifying participants' receipt of the intervention-specifically, whether they opened the intervention message.We completed a preliminary analysis of data from 40 participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Kyung Mi Kim, PhD principal investigator
MandK Consulting Partners
Michele D Nelson, PhD principal investigator
MandK Consulting Partners
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accurate Sleep Data Feedback, Inflated Sleep Data Feedback and Deflated Sleep Data Feedback in people with Sleep and Sleep Quality, run by NextSense, Inc. 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Apr 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?
The study was stopped early (reason given: The study was stopped due to technical difficulties in verifying participants' receipt of the intervention-specifically, whether they opened the intervention message.We completed a preliminary analysis of data from 40 participants.). Results are not available in the source record.
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?
Participant-reported Sleep Quality (time frame: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.). The study lists 4 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 18 Apr 2025.