Alarm Fatigue in Intensive Care Unit NursesNCT07124364
Effects of Relaxation, Mindfulness, and Breathing Therapy on Alarm Fatigue and Psychological Well-being in Intensive Care Nurses
A study testing Benson Relaxation Technique, Mindfulness-Based Stress Reduction Meditation and Breathing Therapy in people with Alarm Fatigue in Intensive Care Unit Nurses and Psychological Well-Being in Intensive Care Unit Nurses, run by Hacer Eroglu at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effects of the Benson Relaxation Technique, mindfulness-based stress reduction meditation, and breathing therapy on reducing alarm fatigue and improving psychological well-being in intensive care unit (ICU) nurses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alarm Fatigue in Intensive Care Unit Nurses, Psychological Well-Being in Intensive Care Unit Nurses
- What is being tested?
- Benson Relaxation Technique, Mindfulness-Based Stress Reduction Meditation and Breathing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 28 Jul 2025to 30 Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Bachelor's degree or higher in nursing
- At least 6 months' experience in a tertiary intensive care unit
- Cognitive and physical ability to complete study forms and perform the assigned exercise with the researcher
- Willingness to participate and provide written informed consent
Who cannot join
- Diagnosed psychological disorders requiring treatment (e.g., anxiety, panic disorder, depression)
- Not actively working during the study period due to leave (e.g., maternity leave, annual leave)
- Concurrent participation in another relaxation exercise program (e.g., yoga, visualization)
- Withdrawal request during the intervention period
- Missing two consecutive weekly group sessions
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Bilkent City Hospital - General Hospital Tower, Internal Medicine and General Intensive Care Units
Ankara, Ankara, 06080
Hacettepe University Hospital
Ankara, Ankara, 06100
About this study
Official title: Comparison of the Effects of Benson Relaxation Technique, Mindfulness-Based Meditation, and Breathing Therapy on Alarm Fatigue and Psychological Well-Being in Intensive Care Nurses: A Four-Arm, Assessor-Blinded, Randomized Controlled Trial
The goal of this clinical trial is to compare the effects of the Benson Relaxation Technique, mindfulness-based stress reduction meditation, and breathing therapy on reducing alarm fatigue and improving psychological well-being in intensive care unit (ICU) nurses.
The main questions it aims to answer are:
Read more
Do the Benson Relaxation Technique, mindfulness-based stress reduction meditation, and breathing therapy significantly reduce alarm fatigue in ICU nurses?
Do these interventions significantly improve psychological well-being in ICU nurses?
Researchers will compare three intervention groups (Benson Relaxation Technique, mindfulness-based stress reduction meditation, breathing therapy) with a control group receiving no intervention to determine which approach produces the greatest improvement in alarm fatigue and psychological well-being.
Participants will:
Attend weekly group sessions for their assigned intervention over the course of [8 weeks].
Practice the assigned technique regularly between sessions as instructed.
Complete questionnaires assessing alarm fatigue and psychological well-being before and after the intervention.
Read the detailed description
This clinical trial was designed to address a gap in the literature regarding effective mind-body approaches for reducing alarm fatigue and supporting psychological well-being among intensive care unit (ICU) nurses. Alarm fatigue is a common and serious concern in ICUs, and interventions that improve nurses' mental health may also enhance patient safety. In this study, three mind-body-based interventions-Benson Relaxation Technique (BRT), mindfulness-based stress reduction meditation (MBSR), and breathing therapy-will be compared in terms of their effects on alarm fatigue and psychological well-being. The comparative findings from this trial are expected to help identify the most effective mind-body-based approach for ICU nurses and support its wider implementation in clinical practice.
Hypotheses
H₀: BRT, MBSR, and breathing therapy have no significant effect on alarm fatigue and psychological well-being in ICU nurses.
H₁: BRT, MBSR, and breathing therapy have a significant effect on alarm fatigue and psychological well-being in ICU nurses.
Study Design This study will employ a four-arm, assessor-blinded, randomized controlled trial design.
Study Setting and Duration The trial will be conducted at three ICU centers: the Internal Medicine and General Intensive Care Units of Ankara Bilkent City Hospital - General Hospital Tower, and the Internal Medicine ICUs of Hacettepe University Adult and Oncology Hospitals. Data collection will take place between June 2025 and June 2026.
Institutional Characteristics The Internal Medicine and General ICUs of Ankara Bilkent City Hospital - General Hospital Tower are tertiary-level units serving approximately 140-150 patients daily, with a total of 70 ICU nurses. The Internal Medicine ICUs of Hacettepe University Adult and Oncology Hospitals serve approximately 200 patients daily across four units, staffed by a total of 100 ICU nurses.
Population and Sample The study population will consist of nurses working in the above-mentioned tertiary ICUs. The sample will include nurses who meet the inclusion criteria, volunteer to participate, and provide written and verbal informed consent. Sample size was calculated based on a previous randomized controlled trial by Askar et al. (2024) examining the effects of progressive muscle relaxation on fatigue in ICU nurses. In that study, mean fatigue scores at week 4 were 3.13±1.58 for the intervention group and 4.12±1.70 for the control group, with a statistically significant difference between groups. Using these findings, an effect size of 0.62, a 95% confidence level, 88% power, and α = 0.05, the minimum required sample size was determined as 42 nurses per group, totaling 168 participants.
Inclusion Criteria
Age ≥ 18 years
Bachelor's degree or higher in nursing
At least 6 months' experience in a tertiary ICU
Cognitive and physical ability to complete study forms and perform the assigned exercise with the researcher
Voluntary participation with signed informed consent
Exclusion Criteria
Diagnosed psychological disorders requiring treatment (e.g., anxiety, panic disorder, depression)
Not actively working during the study period due to leave (e.g., maternity, annual leave)
Concurrent participation in another relaxation exercise program (e.g., yoga, visualization)
Participants will also be withdrawn if they:
Request to leave the study during the intervention period
Miss two consecutive weekly group sessions
Randomization and Blinding Eligible nurses will be randomly assigned (1:1:1:1) to one of the four study arms using www.randomizer.org by the lead researcher. Allocation results will be shared with the second researcher. Interventions will be delivered by a third researcher, while data collection will be performed by a fourth researcher blinded to group allocation. Data analysis will be conducted by a statistician who is also blinded to allocation. Due to the nature of mind-body interventions, participants and the researcher delivering the interventions cannot be blinded; however, the study will maintain assessor blinding.
- Conditions
- Alarm Fatigue in Intensive Care Unit Nurses, Psychological Well-Being in Intensive Care Unit Nurses
- Being tested
- Benson Relaxation Technique, Mindfulness-Based Stress Reduction Meditation, Breathing Therapy
- Keywords
- Alarm fatigue, Psychological well-being, Intensive care nurses, Benson Relaxation Technique, Breathing therapy, Randomized controlled trial, ICU, Nursing intervention
- Medical subject headings
- Alert Fatigue, Health Personnel, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benson Relaxation TechniqueBehavioural
The Benson Relaxation Technique is a structured relaxation method involving the repetition of a word, sound, or phrase while sitting quietly in a comfortable position with eyes closed, combined with passive muscle relaxation. In this study, it will be delivered in weekly 30-minute group sessions for 8 weeks by a trained instructor. Participants will be instructed to practice the technique daily at home for 10-15 minutes.
Mindfulness-Based Stress Reduction MeditationBehavioural
Mindfulness-Based Stress Reduction meditation is a practice focusing on cultivating awareness of the present moment through seated meditation and mindful breathing. In this study, participants will attend weekly 30-minute group sessions for 8 weeks, guided by an experienced instructor. They will also be encouraged to perform daily mindfulness meditation at home for 10-15 minutes.
Breathing TherapyBehavioural
Breathing therapy consists of guided breathing exercises designed to promote relaxation, reduce stress, and improve psychological well-being by regulating breathing patterns. In this study, participants will attend weekly 30-minute group sessions for 8 weeks, led by a trained facilitator. Daily home practice of slow deep breathing techniques for 10-15 minutes will be encouraged.
| Study group | Role | What they receive |
|---|---|---|
| Benson Relaxation Technique Group | Experimental | Participants will receive weekly 30-minute group sessions for 8 weeks to practice the Benson Relaxation Technique under the guidance of a trained instructor. They will also be instructed to perform daily home practice. Receives: Behavioral: Benson Relaxation Technique |
| Mindfulness-Based Stress Reduction Meditation Group | Experimental | Participants will attend weekly 30-minute group sessions for 8 weeks, focusing on seated mindfulness meditation and mindful breathing exercises. They will also be encouraged to practice daily at home. Receives: Behavioral: Mindfulness-Based Stress Reduction Meditation |
| Breathing Therapy Group | Experimental | Participants will attend weekly 30-minute group sessions for 8 weeks, performing guided breathing exercises designed to reduce stress and promote relaxation. Daily home practice will be encouraged. Receives: Behavioral: Breathing Therapy |
| Control Group | No intervention | Participants will not receive any intervention during the study period and will continue their usual routine. After the study ends, they will be offered the opportunity to participate in one of the intervention programs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alarm Fatigue
Alarm fatigue will be measured using the Turkish version of the Healthcare Technology Foundation's Alarm Fatigue Questionnaire, which assesses frequency and perception of alarm-related fatigue among ICU nurses. Higher scores indicate greater fatigue.
Measured: Baseline, at the end of week 4, at the end of week 8, and at the end of week 10
Psychological Well-Being
Psychological well-being will be assessed using the Turkish version of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Higher scores indicate better well-being.
Measured: Baseline, at the end of week 4, at the end of week 8, and at the end of week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start28 Jul 2025
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alarm Fatigue in Intensive Care Unit NursesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four-arm, assessor-blinded, randomized controlled trial with parallel group assignment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacer Eroglu
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent, Hacettepe University
- Responsible party
- Sponsor-investigator, Hacer Eroglu, Hacettepe University
- Investigators
- Zehra Gok Metin, PhD, RN, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124364
- Sponsor's protocol ID
- Record 5
- Status last verified
- Jul 2025
- First submitted
- 9 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including demographic information, baseline and post-intervention outcome measures) will be shared upon reasonable request to the principal investigator, following publication of the study results. Data will be available for 3 years after publication.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Benson Relaxation Technique, Mindfulness-Based Meditation, and Breathing Therapy on Alarm Fatigue and Psychological Well-Being in Intensive Care Nurses: A Four-Arm, Assessor-Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07124364
- Acronym / sponsor ID
- Record 5
- Conditions
- Alarm Fatigue in Intensive Care Unit Nurses, Psychological Well-Being in Intensive Care Unit Nurses
- Keywords
- Alarm fatigue, Psychological well-being, Intensive care nurses, Benson Relaxation Technique, Breathing therapy, Randomized controlled trial, ICU, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Hacer ErogluUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent, Hacettepe University
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 15 Aug 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.
The goal of this clinical trial is to compare the effects of the Benson Relaxation Technique, mindfulness-based stress reduction meditation, and breathing therapy on reducing alarm fatigue and improving psychological well-being in intensive care unit (ICU) nurses.
The main questions it aims to answer are:
Do the Benson Relaxation Technique, mindfulness-based stress reduction meditation, and breathing therapy significantly reduce alarm fatigue in ICU nurses?
Do these interventions significantly improve psychological well-being in ICU nurses?
Researchers will compare three intervention groups (Benson Relaxation Technique, mindfulness-based stress reduction meditation, breathing therapy) with a control group receiving no intervention to determine which approach produces the greatest improvement in alarm fatigue and psychological well-being.
Participants will:
Attend weekly group sessions for their assigned intervention over the course of [8 weeks].
Practice the assigned technique regularly between sessions as instructed.
Complete questionnaires assessing alarm fatigue and psychological well-being before and after the intervention.
Detailed description
This clinical trial was designed to address a gap in the literature regarding effective mind-body approaches for reducing alarm fatigue and supporting psychological well-being among intensive care unit (ICU) nurses. Alarm fatigue is a common and serious concern in ICUs, and interventions that improve nurses' mental health may also enhance patient safety. In this study, three mind-body-based interventions-Benson Relaxation Technique (BRT), mindfulness-based stress reduction meditation (MBSR), and breathing therapy-will be compared in terms of their effects on alarm fatigue and psychological well-being. The comparative findings from this trial are expected to help identify the most effective mind-body-based approach for ICU nurses and support its wider implementation in clinical practice.
Hypotheses
H₀: BRT, MBSR, and breathing therapy have no significant effect on alarm fatigue and psychological well-being in ICU nurses.
H₁: BRT, MBSR, and breathing therapy have a significant effect on alarm fatigue and psychological well-being in ICU nurses.
Study Design This study will employ a four-arm, assessor-blinded, randomized controlled trial design.
Study Setting and Duration The trial will be conducted at three ICU centers: the Internal Medicine and General Intensive Care Units of Ankara Bilkent City Hospital - General Hospital Tower, and the Internal Medicine ICUs of Hacettepe University Adult and Oncology Hospitals. Data collection will take place between June 2025 and June 2026.
Institutional Characteristics The Internal Medicine and General ICUs of Ankara Bilkent City Hospital - General Hospital Tower are tertiary-level units serving approximately 140-150 patients daily, with a total of 70 ICU nurses. The Internal Medicine ICUs of Hacettepe University Adult and Oncology Hospitals serve approximately 200 patients daily across four units, staffed by a total of 100 ICU nurses.
Population and Sample The study population will consist of nurses working in the above-mentioned tertiary ICUs. The sample will include nurses who meet the inclusion criteria, volunteer to participate, and provide written and verbal informed consent. Sample size was calculated based on a previous randomized controlled trial by Askar et al. (2024) examining the effects of progressive muscle relaxation on fatigue in ICU nurses. In that study, mean fatigue scores at week 4 were 3.13±1.58 for the intervention group and 4.12±1.70 for the control group, with a statistically significant difference between groups. Using these findings, an effect size of 0.62, a 95% confidence level, 88% power, and α = 0.05, the minimum required sample size was determined as 42 nurses per group, totaling 168 participants.
Inclusion Criteria
Age ≥ 18 years
Bachelor's degree or higher in nursing
At least 6 months' experience in a tertiary ICU
Cognitive and physical ability to complete study forms and perform the assigned exercise with the researcher
Voluntary participation with signed informed consent
Exclusion Criteria
Diagnosed psychological disorders requiring treatment (e.g., anxiety, panic disorder, depression)
Not actively working during the study period due to leave (e.g., maternity, annual leave)
Concurrent participation in another relaxation exercise program (e.g., yoga, visualization)
Participants will also be withdrawn if they:
Request to leave the study during the intervention period
Miss two consecutive weekly group sessions
Randomization and Blinding Eligible nurses will be randomly assigned (1:1:1:1) to one of the four study arms using www.randomizer.org by the lead researcher. Allocation results will be shared with the second researcher. Interventions will be delivered by a third researcher, while data collection will be performed by a fourth researcher blinded to group allocation. Data analysis will be conducted by a statistician who is also blinded to allocation. Due to the nature of mind-body interventions, participants and the researcher delivering the interventions cannot be blinded; however, the study will maintain assessor blinding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four-arm, assessor-blinded, randomized controlled trial with parallel group assignment.
| Arm | Type | Receives |
|---|---|---|
| Benson Relaxation Technique Group | Experimental | Behavioral: Benson Relaxation TechniqueParticipants will receive weekly 30-minute group sessions for 8 weeks to practice the Benson Relaxation Technique under the guidance of a trained instructor. They will also be instructed to perform daily home practice. |
| Mindfulness-Based Stress Reduction Meditation Group | Experimental | Behavioral: Mindfulness-Based Stress Reduction MeditationParticipants will attend weekly 30-minute group sessions for 8 weeks, focusing on seated mindfulness meditation and mindful breathing exercises. They will also be encouraged to practice daily at home. |
| Breathing Therapy Group | Experimental | Behavioral: Breathing TherapyParticipants will attend weekly 30-minute group sessions for 8 weeks, performing guided breathing exercises designed to reduce stress and promote relaxation. Daily home practice will be encouraged. |
| Control Group | No intervention | –Participants will not receive any intervention during the study period and will continue their usual routine. After the study ends, they will be offered the opportunity to participate in one of the intervention programs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Bachelor's degree or higher in nursing
- At least 6 months' experience in a tertiary intensive care unit
- Cognitive and physical ability to complete study forms and perform the assigned exercise with the researcher
- Willingness to participate and provide written informed consent
Key exclusion criteria (5 listed)
- Diagnosed psychological disorders requiring treatment (e.g., anxiety, panic disorder, depression)
- Not actively working during the study period due to leave (e.g., maternity leave, annual leave)
- Concurrent participation in another relaxation exercise program (e.g., yoga, visualization)
- Withdrawal request during the intervention period
- Missing two consecutive weekly group sessions
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 |
|---|---|---|
| Benson Relaxation TechniqueThe Benson Relaxation Technique is a structured relaxation method involving the repetition of a word, sound, or phrase while sitting quietly in a comfortable position with eyes closed, combined with passive muscle relaxation. In this study, it will be delivered in weekly 30-minute group sessions for 8 weeks by a trained instructor. Participants will be instructed to practice the technique daily at home for 10-15 minutes. | Behavioural | Benson Relaxation Technique Group |
| Mindfulness-Based Stress Reduction MeditationMindfulness-Based Stress Reduction meditation is a practice focusing on cultivating awareness of the present moment through seated meditation and mindful breathing. In this study, participants will attend weekly 30-minute group sessions for 8 weeks, guided by an experienced instructor. They will also be encouraged to perform daily mindfulness meditation at home for 10-15 minutes. | Behavioural | Mindfulness-Based Stress Reduction Meditation Group |
| Breathing TherapyBreathing therapy consists of guided breathing exercises designed to promote relaxation, reduce stress, and improve psychological well-being by regulating breathing patterns. In this study, participants will attend weekly 30-minute group sessions for 8 weeks, led by a trained facilitator. Daily home practice of slow deep breathing techniques for 10-15 minutes will be encouraged. | Behavioural | Breathing Therapy Group |
Primary outcome
Alarm Fatigue
Time frame: Baseline, at the end of week 4, at the end of week 8, and at the end of week 10
Alarm fatigue will be measured using the Turkish version of the Healthcare Technology Foundation's Alarm Fatigue Questionnaire, which assesses frequency and perception of alarm-related fatigue among ICU nurses. Higher scores indicate greater fatigue.
Psychological Well-Being
Time frame: Baseline, at the end of week 4, at the end of week 8, and at the end of week 10
Psychological well-being will be assessed using the Turkish version of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Higher scores indicate better well-being.
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 15 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including demographic information, baseline and post-intervention outcome measures) will be shared upon reasonable request to the principal investigator, following publication of the study results. Data will be available for 3 years after publication.
Related trials for Alarm Fatigue in Intensive Care Unit Nurses
Enrolling by invitation
Intervention Program for Alarm Fatigue in NICU Nurses Based on ABC-X Model
Alert Fatigue, Health Personnel
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.
Zehra Gok Metin, PhD, RN principal investigator
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benson Relaxation Technique, Mindfulness-Based Stress Reduction Meditation and Breathing Therapy in people with Alarm Fatigue in Intensive Care Unit Nurses and Psychological Well-Being in Intensive Care Unit Nurses, run by Hacer Eroglu at 2 sites in Turkey (Türkiye).
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 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. 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 Turkey (Türkiye). 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?
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?
Alarm Fatigue (time frame: Baseline, at the end of week 4, at the end of week 8, and at the end of week 10). The study lists 2 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 15 Aug 2025.