SleepNCT07925606
Effect of Sufi Music on Sleep, Cardiac Symptoms and Vital Signs in Open-Heart Surgery Patients
A study testing Sufi music in people with Sleep and Cardiac Symptoms, run by Yeliz Ciğerci.
Trial summary
The aim of this randomised, double-blind, controlled experimental study is to investigate the effect of Sufi music delivered via a bone-conduction pillow speaker on sleep quality, cardiac symptoms and vital signs in open-heart surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep, Cardiac Symptoms, Vital Signs
- What is being tested?
- Sufi music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 15 Apr 2028
- 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
- Aged 18 years or older,
- Literate in Turkish (able to read and write),
- Having undergone elective open-heart surgery (coronary artery bypass graft surgery) and extubated after the operation,
- Fully oriented to place, time and person and fully cooperative,
- Able to complete the cognitive function assessment scales,
- Planned to receive inpatient treatment in the clinical setting for at least two days and receiving inpatient treatment in the ward at the time of the study (21:30),
- Without severe hearing loss that would impair bone-conduction sound transmission or the perception of verbal instructions,
- Patients who voluntarily agree to participate and sign the Informed Voluntary Consent Form will be included in the study.
Who cannot join
- Undergoing emergency surgery, Having a severe neurological deficit (e.g., cerebrovascular event) or a diagnosed psychiatric disorder, Requiring mechanical ventilator support for longer than 24 hours in the postoperative period, Having persistent haemodynamic instability, requiring an intra-aortic balloon pump, or receiving high-dose inotropic support, Having a history of diagnosed sleep apnoea or chronic insomnia, Having received sedative, hypnotic, anxiolytic or strong analgesic (e.g., opioid) medication within 4-6 hours before the intervention time, Having severe pain (VAS >4) requiring analgesic treatment before the intervention, Having an open wound, lesion, burn or acute surgical incision in the temporal/mastoid region or the cranial bones where the bone-conduction pillow speaker will make contact, and patients using a cochlear implant whose device cannot be removed in the evening hours.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Sufi Music Delivered Via a Bone-Conduction Pillow Speaker on Sleep Quality, Cardiac Symptoms and Vital Signs in Open-Heart Surgery Patients: A Randomised Controlled Trial
The aim of this randomised, double-blind, controlled experimental study is to investigate the effect of Sufi music delivered via a bone-conduction pillow speaker on sleep quality, cardiac symptoms and vital signs in open-heart surgery patients. The study will be conducted with three groups, each comprising 30 patients (90 in total): an intervention group, a sham group and a routine care control group. Participants in the intervention group will listen to relaxing Sufi music without percussion for 15-20 minutes, starting at 21:30, through a bone-conduction pillow speaker placed under the pillow. Participants in the sham group will have an identical-looking pillow speaker placed under their pillow for the same duration, but no sound will be transmitted. Participants in the control group will receive only the hospital's standard night-care protocol, with no device or music intervention. Vital signs (blood pressure, pulse, respiratory rate and oxygen saturation) will be measured immediately before and after the application period in all groups, and sleep quality will be assessed the following morning between 08:00 and 09:00 using the Richards-Campbell Sleep Questionnaire. Cardiac symptoms will be assessed in all groups with a Cardiac Symptom Survey before discharge.
Read the detailed description
Cardiovascular diseases are among the leading causes of morbidity and mortality, affecting millions of people worldwide each year. Pharmacological, interventional and surgical methods are used in their treatment. Open-heart surgery is performed as a life-saving procedure in the treatment of coronary artery disease and valvular heart disease. It is estimated that approximately 1-1.5 million cardiac surgical procedures are performed worldwide every year. In Türkiye, too, cardiac surgery is an important area of healthcare delivery; it has been reported that more than 70,000 heart operations were performed in the 2022-2023 period, a considerable proportion of which were coronary artery bypass graft (CABG) surgeries.
After CABG surgery, patients face multidimensional problems such as pain, anxiety, sleep disturbance and haemodynamic fluctuations. In particular, during the intensive care and early ward period, noise, immobility, mechanical ventilation, pain and environmental stressors disrupt sleep continuity, which adversely affects recovery, rehabilitation and overall prognosis. Impaired sleep quality may weaken immune function and delay wound healing, thereby negatively affecting the postoperative recovery process. Sleep, which is an important component of physical and psychological well-being, has been reported to be impaired in 48-90% of patients after cardiac surgery, and this disturbance may persist in the days following surgery.
Cardiac symptoms such as chest pain, dyspnoea, fatigue, leg swelling and palpitations are very common in both the early and late recovery periods after CABG. Chronic chest pain and arrhythmias restrict patients' activities of daily living and adversely affect the recovery process and quality of life. One study reported that postoperative arrhythmia developed in 54% of patients who underwent open-heart surgery, with sinus tachycardia being the most common arrhythmia (66.7%). Dyspnoea, in turn, is associated with pulmonary complications that may develop after cardiopulmonary bypass and may increase morbidity. Fatigue and weakness, which are commonly observed in the postoperative period, may also negatively affect patients' recovery. Therefore, maintaining cardiac function, ensuring adequate tissue perfusion and preserving vital signs are among the fundamental components of postoperative care after open-heart surgery.
Studies have shown that non-pharmacological approaches significantly improve sleep quality after cardiac surgery and also reduce pain and anxiety. Music-based interventions stand out as a low-cost, feasible complementary approach with a low risk of serious adverse effects in cardiac surgery patients. One study reported that a music intervention was an effective complementary intervention for prolonging sleep duration and improving sleep quality in the early postoperative period in patients undergoing mechanical mitral valve replacement. In addition, there are studies indicating that music interventions may have favourable effects on certain physiological indicators, such as heart rate, blood pressure and oxygen saturation, following cardiac and cardiothoracic surgery. In patients undergoing open-heart surgery, music interventions have been reported to reduce anxiety, shorten the length of intensive care and hospital stay, and improve some vital signs.
Bone-conduction sound technology allows auditory stimuli to be delivered through a different transmission mechanism; integrating this technology into contact surfaces such as pillows offers an alternative approach for presenting auditory stimuli before sleep. Although the beneficial effects of music interventions on pain, anxiety and certain physiological parameters after cardiac surgery are supported, research that simultaneously examines the effects of Sufi music and the use of a bone-conduction pillow speaker on cardiac symptoms and sleep quality in patients undergoing open-heart surgery is very limited. Therefore, this study aims to examine the effect of Sufi music delivered via a bone-conduction pillow speaker on sleep quality, cardiac symptoms and vital signs in patients undergoing open-heart surgery.
- Conditions
- Sleep, Cardiac Symptoms, Vital Signs
- Being tested
- Sufi music, Placebo
- Keywords
- Open-Heart Surgery, Patients, Sufi Music, sleep, cardiac symptoms, vital signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufi musicOther
Pre-intervention: At 21:30, patients' vital signs, consisting of blood pressure, pulse, respiratory rate and oxygen saturation, will be measured and recorded before the intervention.
Intervention: A bone-conduction pillow speaker will be placed under the patients' pillows. Starting at 21:30, patients will listen to relaxing Sufi music without percussion for 15-20 minutes. The music will be delivered via the bone-conduction pillow speaker to isolate the patient from external noise.
Post-intervention: Immediately after the intervention ends, patients' vital signs will be measured and recorded again.
PlaceboOther
Pre-intervention: At 21:30, pre-intervention vital signs will be measured and recorded in exactly the same manner as in the intervention group.
Intervention: A bone-conduction pillow speaker identical in appearance to the one used in the intervention group will be placed under the patients' pillows; however, no sound or music will be transmitted to the device (passive device application). Patients will remain in contact with the pillow for the same duration (15-20 minutes). Patients will be informed that a module transmitting sound at a special low/subliminal frequency that cannot be directly heard by the human ear is being applied.
Post-intervention: Immediately after the designated period has elapsed, patients' post-intervention vital signs will be measured and recorded again.
Following morning: On the following morning, within the designated time interval, the Richards-Campbell Sleep Questionnaire will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Sufi Music Group | Experimental | A bone-conduction pillow speaker will be placed under the patients' pillows. Starting at 21:30, patients will listen to relaxing Sufi music without percussion for 15-20 minutes. The music will be delivered via the bone-conduction pillow speaker to isolate the patient from external noise. Receives: Other: Sufi music |
| Sham (Placebo) Group | Placebo comparator | A bone-conduction pillow speaker identical in appearance to the one used in the intervention group will be placed under the patients' pillows; however, no sound or music will be transmitted to the device (passive device application). Patients will remain in contact with the pillow for the same duration (15-20 minutes). Patients will be informed that a module transmitting sound at a special low/subliminal frequency that cannot be directly heard by the human ear is being applied. Receives: Other: Placebo |
| Control group | No intervention | No device or music intervention will be applied to the patients; only the hospital's standard night-care protocol will be continued. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richards-Campbell Sleep Questionnaire
This questionnaire was developed by Richards (1987) to assess the sleep quality of patients in intensive care and clinical settings [28], and its Turkish validity and reliability study was conducted by Özlü and Özer (2015) [29]. The questionnaire consists of six items and is scored on a scale of 0 to 100. However, the sixth item, which measures external stimuli/environmental factors (noise level), is not included in the calculation of the total score. The overall sleep quality score is calculated by dividing the sum of the scores obtained from the first five items by the number of items. The minimum score that can be obtained from the questionnaire is 0 and the maximum is 100. Higher scores indicate better sleep quality. In the evaluation, a score range of "0-25" represents very poor sleep quality, whereas a range of "76-100" represents very good sleep quality. The internal consistency
Measured: Befor surgery (preoperative) and the morning following the intervention night (between 08:00 and 09:00)
Secondary outcomes (1)
Cardiac Symptom Survey
The scale developed by Nieveen et al. (2008) [32] was adapted into Turkish, with validity and reliability analyses conducted by Özkan and Taştan (2016) [33]. The scale covers a total of 10 core cardiac symptoms: chest pain, shortness of breath, fatigue, feeling sad, sleep problems, pain at the surgical site, leg swelling, palpitations, anxiety and loss of appetite. The scale is structurally composed of three main dimensions, namely "symptom perception", "symptom appraisal" and "response to symptoms", and assessments are made on a Likert-type scale scored from 0 to 10. A score of "0" indicates that the symptom is absent or does not affect the patient, whereas "10" represents the highest negative impact of the symptom on the patient. In the appraisal dimension, the mean of the frequency and severity of each symptom is calculated, whereas in the response dimension, the degree to which symptoms limit phy
Measured: Befor surgery (preoperative) and the morning following the intervention night (between 08:00 and 09:00)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Apr 2028 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeliz Ciğerci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yeliz Ciğerci, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925606
- Sponsor's protocol ID
- 2026/3
- Status last verified
- Nov 2026
- First submitted
- 4 Nov 2026
- Last updated
- 9 Nov 2026
- 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 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sufi Music Delivered Via a Bone-Conduction Pillow Speaker on Sleep Quality, Cardiac Symptoms and Vital Signs in Open-Heart Surgery Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07925606
- Acronym / sponsor ID
- 2026/3
- Conditions
- Sleep, Cardiac Symptoms, Vital Signs
- Keywords
- Open-Heart Surgery, Patients, Sufi Music, sleep, cardiac symptoms, vital signs
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yeliz CiğerciUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 9 Nov 2026 (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 aim of this randomised, double-blind, controlled experimental study is to investigate the effect of Sufi music delivered via a bone-conduction pillow speaker on sleep quality, cardiac symptoms and vital signs in open-heart surgery patients. The study will be conducted with three groups, each comprising 30 patients (90 in total): an intervention group, a sham group and a routine care control group. Participants in the intervention group will listen to relaxing Sufi music without percussion for 15-20 minutes, starting at 21:30, through a bone-conduction pillow speaker placed under the pillow. Participants in the sham group will have an identical-looking pillow speaker placed under their pillow for the same duration, but no sound will be transmitted. Participants in the control group will receive only the hospital's standard night-care protocol, with no device or music intervention. Vital signs (blood pressure, pulse, respiratory rate and oxygen saturation) will be measured immediately before and after the application period in all groups, and sleep quality will be assessed the following morning between 08:00 and 09:00 using the Richards-Campbell Sleep Questionnaire. Cardiac symptoms will be assessed in all groups with a Cardiac Symptom Survey before discharge.
Detailed description
Cardiovascular diseases are among the leading causes of morbidity and mortality, affecting millions of people worldwide each year. Pharmacological, interventional and surgical methods are used in their treatment. Open-heart surgery is performed as a life-saving procedure in the treatment of coronary artery disease and valvular heart disease. It is estimated that approximately 1-1.5 million cardiac surgical procedures are performed worldwide every year. In Türkiye, too, cardiac surgery is an important area of healthcare delivery; it has been reported that more than 70,000 heart operations were performed in the 2022-2023 period, a considerable proportion of which were coronary artery bypass graft (CABG) surgeries.
After CABG surgery, patients face multidimensional problems such as pain, anxiety, sleep disturbance and haemodynamic fluctuations. In particular, during the intensive care and early ward period, noise, immobility, mechanical ventilation, pain and environmental stressors disrupt sleep continuity, which adversely affects recovery, rehabilitation and overall prognosis. Impaired sleep quality may weaken immune function and delay wound healing, thereby negatively affecting the postoperative recovery process. Sleep, which is an important component of physical and psychological well-being, has been reported to be impaired in 48-90% of patients after cardiac surgery, and this disturbance may persist in the days following surgery.
Cardiac symptoms such as chest pain, dyspnoea, fatigue, leg swelling and palpitations are very common in both the early and late recovery periods after CABG. Chronic chest pain and arrhythmias restrict patients' activities of daily living and adversely affect the recovery process and quality of life. One study reported that postoperative arrhythmia developed in 54% of patients who underwent open-heart surgery, with sinus tachycardia being the most common arrhythmia (66.7%). Dyspnoea, in turn, is associated with pulmonary complications that may develop after cardiopulmonary bypass and may increase morbidity. Fatigue and weakness, which are commonly observed in the postoperative period, may also negatively affect patients' recovery. Therefore, maintaining cardiac function, ensuring adequate tissue perfusion and preserving vital signs are among the fundamental components of postoperative care after open-heart surgery.
Studies have shown that non-pharmacological approaches significantly improve sleep quality after cardiac surgery and also reduce pain and anxiety. Music-based interventions stand out as a low-cost, feasible complementary approach with a low risk of serious adverse effects in cardiac surgery patients. One study reported that a music intervention was an effective complementary intervention for prolonging sleep duration and improving sleep quality in the early postoperative period in patients undergoing mechanical mitral valve replacement. In addition, there are studies indicating that music interventions may have favourable effects on certain physiological indicators, such as heart rate, blood pressure and oxygen saturation, following cardiac and cardiothoracic surgery. In patients undergoing open-heart surgery, music interventions have been reported to reduce anxiety, shorten the length of intensive care and hospital stay, and improve some vital signs.
Bone-conduction sound technology allows auditory stimuli to be delivered through a different transmission mechanism; integrating this technology into contact surfaces such as pillows offers an alternative approach for presenting auditory stimuli before sleep. Although the beneficial effects of music interventions on pain, anxiety and certain physiological parameters after cardiac surgery are supported, research that simultaneously examines the effects of Sufi music and the use of a bone-conduction pillow speaker on cardiac symptoms and sleep quality in patients undergoing open-heart surgery is very limited. Therefore, this study aims to examine the effect of Sufi music delivered via a bone-conduction pillow speaker on sleep quality, cardiac symptoms and vital signs in patients undergoing open-heart surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Sufi Music Group | Experimental | Other: Sufi musicA bone-conduction pillow speaker will be placed under the patients' pillows. Starting at 21:30, patients will listen to relaxing Sufi music without percussion for 15-20 minutes. The music will be delivered via the bone-conduction pillow speaker to isolate the patient from external noise. |
| Sham (Placebo) Group | Placebo comparator | Other: PlaceboA bone-conduction pillow speaker identical in appearance to the one used in the intervention group will be placed under the patients' pillows; however, no sound or music will be transmitted to the device (passive device application). Patients will remain in contact with the pillow for the same duration (15-20 minutes). Patients will be informed that a module transmitting sound at a special low/subliminal frequency that cannot be directly heard by the human ear is being applied. |
| Control group | No intervention | –No device or music intervention will be applied to the patients; only the hospital's standard night-care protocol will be continued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years or older,
- Literate in Turkish (able to read and write),
- Having undergone elective open-heart surgery (coronary artery bypass graft surgery) and extubated after the operation,
- Fully oriented to place, time and person and fully cooperative,
- Able to complete the cognitive function assessment scales,
Key exclusion criteria (1 listed)
- Undergoing emergency surgery, Having a severe neurological deficit (e.g., cerebrovascular event) or a diagnosed psychiatric disorder, Requiring mechanical ventilator support for longer than 24 hours in the postoperative period, Having persistent haemodynamic instability, requiring an intra-aortic balloon pump, or receiving high-dose inotropic support, Having a history of diagnosed sleep apnoea or chronic insomnia, Having received sedative, hypnotic, anxiolytic or strong analgesic (e.g., opioid) medication within 4-6 hours before the intervention time, Having severe pain (VAS >4) requiring analgesic treatment before the intervention, Having an open wound, lesion, burn or acute surgical incision in the temporal/mastoid region or the cranial bones where the bone-conduction pillow speaker will make contact, and patients using a cochlear implant whose device cannot be removed in the evening hours.
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 |
|---|---|---|
| Sufi musicPre-intervention: At 21:30, patients' vital signs, consisting of blood pressure, pulse, respiratory rate and oxygen saturation, will be measured and recorded before the intervention. Intervention: A bone-conduction pillow speaker will be placed under the patients' pillows. Starting at 21:30, patients will listen to relaxing Sufi music without percussion for 15-20 minutes. The music will be delivered via the bone-conduction pillow speaker to isolate the patient from external noise. Post-intervention: Immediately after the intervention ends, patients' vital signs will be measured and recorded again. | Other | Experimental Group: Sufi Music Group |
| PlaceboPre-intervention: At 21:30, pre-intervention vital signs will be measured and recorded in exactly the same manner as in the intervention group. Intervention: A bone-conduction pillow speaker identical in appearance to the one used in the intervention group will be placed under the patients' pillows; however, no sound or music will be transmitted to the device (passive device application). Patients will remain in contact with the pillow for the same duration (15-20 minutes). Patients will be informed that a module transmitting sound at a special low/subliminal frequency that cannot be directly heard by the human ear is being applied. Post-intervention: Immediately after the designated period has elapsed, patients' post-intervention vital signs will be measured and recorded again. Following morning: On the following morning, within the designated time interval, the Richards-Campbell Sleep Questionnaire will be administered. | Other | Sham (Placebo) Group |
Primary outcome
Richards-Campbell Sleep Questionnaire
Time frame: Befor surgery (preoperative) and the morning following the intervention night (between 08:00 and 09:00)
This questionnaire was developed by Richards (1987) to assess the sleep quality of patients in intensive care and clinical settings [28], and its Turkish validity and reliability study was conducted by Özlü and Özer (2015) [29]. The questionnaire consists of six items and is scored on a scale of 0 to 100. However, the sixth item, which measures external stimuli/environmental factors (noise level), is not included in the calculation of the total score. The overall sleep quality score is calculated by dividing the sum of the scores obtained from the first five items by the number of items. The minimum score that can be obtained from the questionnaire is 0 and the maximum is 100. Higher scores indicate better sleep quality. In the evaluation, a score range of "0-25" represents very poor sleep quality, whereas a range of "76-100" represents very good sleep quality. The internal consistency
1 secondary outcome
Cardiac Symptom Survey
Time frame: Befor surgery (preoperative) and the morning following the intervention night (between 08:00 and 09:00)
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 9 Nov 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Sufi music in people with Sleep and Cardiac Symptoms, run by Yeliz Ciğerci.
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 8 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Yeliz CİĞERCi (0555 217 29 48, yeliz.ceylin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richards-Campbell Sleep Questionnaire (time frame: Befor surgery (preoperative) and the morning following the intervention night (between 08:00 and 09:00)). 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 9 Nov 2026.