Postoperative Sleep DisturbancePhase 3NCT06281561
Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance
A Phase 3 study testing Normal Saline and Dexmedetomidine in people with Postoperative Sleep Disturbance, run by The First Affiliated Hospital of Xiamen University.
Trial summary
The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. Read more about this study
- Who is it for?
- Ages 23 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sleep Disturbance
- What is being tested?
- Normal Saline and Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Phase 3
- 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 23 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Patients undergoing hysteroscopy in the hospital;2. American Society of Anesthesiologists Classification (ASA) I-II;3.No significant cardiovascular disease, liver, and kidney function within normal limits;4.Fully informed about the study and willing to participate by signing the informed consent form.
Who cannot join
- 1. ASA III-IV, severe cardiovascular disease, or poor physical condition;2. History of mental illness;3. History of sedative or antipsychotic drug use (neuroinhibitors, anxiolytics, antidepressants, benzodiazepines) for any reason;4. History of sleep disorders or have night shifts;5. Surgical complications (bleeding, reoperation, meningitis);6. Nasal deformity or nasal trauma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Intranasal Dexmedetomidine Premedication on Sleep Disturbance After General Anaesthesia
The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance.
Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery.
Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality.
Read the detailed description
General anesthesia induces a drug-dependent state of unconsciousness and disrupts the normal 90-minute cycles of non-REM and REM sleep, resulting in significant suppression of physiological sleep during the postoperative period. This can lead to complications such as daytime fatigue, anxiety, pain, and a significant impact on mental and cognitive function. Currently, no effective interventions have been identified to prevent postoperative sleep disturbance. Dexmedetomidine induces a distinct sedative response, with a easy transition from sleep to wakefulness and deep sedation similar to natural sleep, while maintaining forebrain connectivity. This has clinical implications for reducing postoperative sleep disturbances by exploring optimal combinations of anaesthetic drugs.
In this study, all subjects meeting the inclusion criteria will be randomly assigned to one of three groups: Dexmedetomidine 0.2 ug/kg, Dexmedetomidine 0.5 ug/kg and normal saline as control group. All dexmedetomidine solutions were diluted to 0.6ml at different doses and prepared by a senior nurse who was not involved in the follow-up. All patients received no preoperative medication. On arrival in the waiting room, all patients were examined and received an intranasal spray of a total volume of 0.6ml 25 minutes before anesthesia. Patients, anesthetists, gynecologists and nurses were all blinded to group allocation. Patients received an intravenous cannula with lactated Ringer's solution. Heart rate, non-invasive blood pressure, electrocardiogram, and SpO2 and BIS were monitored during hysteroscopic procedures. Propofol was administered via the TCI infusion system using the Marsh pharmacokinetic parameters with a target plasma concentration of 3.2 ng/ml in three groups. The initial starting dose of propofol was based on the results of our pre-test and BIS. If the target was achieved and the BIS was <50, remifentanil was given at 1 ug/kg by pump and LMA was then placed. During the hysteroscopy, TCI was regulated according to the up and down method of Dixon, first described in 1965. TCI was upregulated by 0.1-0.2 when patients had a somatic response （unintended movement of the angelus orris or limbs） during cervical dilation. In the absence of limb movement, the subsequent target plasma concentration was reduced by 0.1 ng/ml. Emergency equipment and drugs were available at all times.
Early recovery will be evaluated in PACU and Later recovery will be measured using QoR-40 questionnaire. Sleep quality was monitored using a wearable device and assessed using the Pittsburgh Sleep Quality Index questionnaire 1-2 days before surgery and 1, 3, and 7 days after surgery.
- Conditions
- Postoperative Sleep Disturbance
- Being tested
- Normal Saline, Dexmedetomidine
- Keywords
- Sleep Disturbance, Dexmedetomidine, Anesthesia, propofol
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Female patients undergoing hysteroscopy receive nasal spray with normal saline before anesthesia
DexmedetomidineDrug
Female patients undergoing hysteroscopy receive nasal spray with dexmedetomidine before anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Nasal spray with nomal saline before anesthesia Receives: Drug: Normal Saline |
| Dexmedetomidine | Experimental | Nasal spray with dexmedetomidine before anesthesia Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline sleep quality at after intervention
Wearable devices continuously records Night sleep duration, deep sleep proportion, light sleep proportion, rapid eye movement (REM) proportion, deep sleep continuity, waking times, and breathing quality.All these parameters are registered and combined in a report that indicates the degree of quality of the person's sleep as good, fair or poor.
Measured: 1-2 day before and 7 days after anesthesia exposure
Pittsburgh sleep quality index(PSQI)
Total scores range from 0 to 21, with higher scores indicating worse sleep quality. PSQI≥8 was defined as sleep disorder.
Measured: 1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.
Secondary outcomes (2)
Early recovery evaluated by Aldrete rating scale
The total score is 10 points. Higher scores indicate better rehabilitation. When the patient's score was > 9, the patient could be considered for transfer out of PACU
Measured: Post anesthesia care unit time
Later Recovery evaluated by QoR-40 questionnaire
The maximum total score is 200, with higher scores indicating better recovery quality
Measured: QoR-40 score on the third day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Bin, The First Affiliated Hospital of Xiamen University
- Investigators
- BIN YANG, Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281561
- Sponsor's protocol ID
- FirstAHXiamenU-YB
- Status last verified
- Apr 2024
- First submitted
- 6 Feb 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We expect to release the original data on the ResMan original data sharing platform （IPD sharing platform）.
Publications
Wang X, Hua D, Tang X, Li S, Sun R, Xie Z, Zhou Z, Zhao Y, Wang J, Li S, Luo A. The Role of Perioperative Sleep Disturbance in Postoperative Neurocognitive Disorders. Nat Sci Sleep. 2021 Aug 6;13:1395-1410. doi: 10.2147/NSS.S320745. eCollection 2021.
PubMed 34393534Purcell KF, Scarcella N, Chun D, Holland C, Stauffer TP, Bolognesi M, Lachiewicz P. Treating Sleep Disorders After Total Hip and Total Knee Arthroplasty. Orthop Clin North Am. 2023 Oct;54(4):397-405. doi: 10.1016/j.ocl.2023.05.008. Epub 2023 Jul 11.
PubMed 37718079Yu S, Xiong Y, Lu G, Xiong X. Effects of Preoperative Sleep Disorders on Anesthesia Recovery and Postoperative Pain in Patients Undergoing Laparoscopic Gynecological Surgery under General Anesthesia. Mediators Inflamm. 2022 Dec 15;2022:7998104. doi: 10.1155/2022/7998104. eCollection 2022.
PubMed 36570021Jia X, Song Y, Li Z, Yang N, Liu T, Han D, Sun Z, Shi C, Zhou Y, Shi J, Liu Y, Guo X. Melatonin regulates the circadian rhythm to ameliorate postoperative sleep disorder and neurobehavioral abnormalities in aged mice. CNS Neurosci Ther. 2024 Mar;30(3):e14436. doi: 10.1111/cns.14436. Epub 2023 Sep 22.
PubMed 37736695Shi Y, Sun Q, Wang Y, Chen C, Jin J, Wang W, Lu Y, Hua Y, Liu J, Bian J, Yi Z. Can dexamethasone improve postoperative sleep and postoperative delirium in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy? Protocol for a prospective, randomized, double-blind, controlled study. Trials. 2023 Aug 8;24(1):505. doi: 10.1186/s13063-023-07521-8.
PubMed 37550718Zhang Y, Tan SL, Du J, Chen Y, Jia J, Feng JG, Liu KX, Zhou J. Dexmedetomidine alleviates neuroinflammation, restores sleep disorders and neurobehavioral abnormalities in rats with minimal hepatic encephalopathy. Int Immunopharmacol. 2021 Jul;96:107795. doi: 10.1016/j.intimp.2021.107795. Epub 2021 May 24.
PubMed 34162157De Zen L, Divisic A, Molinaro G, Solidoro S, Barbi E. Dexmedetomidine at Home for Intractable Dystonia and Insomnia in Children With Special Needs: A Case Series. J Pain Symptom Manage. 2023 Dec;66(6):e653-e657. doi: 10.1016/j.jpainsymman.2023.07.018. Epub 2023 Aug 5.
PubMed 37544550Wang L, Qiu G, Li X, Yang B. Intranasal low-dose dexmedetomidine alleviates propofol-associated postoperative sleep disturbance in female hysteroscopy patients: a randomized controlled trial. BMC Anesthesiol. 2026 Feb 27;26(1):213. doi: 10.1186/s12871-026-03720-3.
PubMed 41761098Li X, Yan L, Wang L, Chen H, Yang B. Study on the preventive effect of dexmedetomidine on anesthetic associated sleep disturbance in young to middle-aged female patients undergoing hysteroscopy: a study protocol for a crossover randomized controlled trial. Trials. 2024 Jul 15;25(1):480. doi: 10.1186/s13063-024-08311-6.
PubMed 39010171
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intranasal Dexmedetomidine Premedication on Sleep Disturbance After General Anaesthesia
- ClinicalTrials.gov ID
- NCT06281561
- Acronym / sponsor ID
- FirstAHXiamenU-YB
- Conditions
- Postoperative Sleep Disturbance
- Keywords
- Sleep Disturbance, Dexmedetomidine, Anesthesia, propofol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Feb 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 goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance.
Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery.
Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality.
Detailed description
General anesthesia induces a drug-dependent state of unconsciousness and disrupts the normal 90-minute cycles of non-REM and REM sleep, resulting in significant suppression of physiological sleep during the postoperative period. This can lead to complications such as daytime fatigue, anxiety, pain, and a significant impact on mental and cognitive function. Currently, no effective interventions have been identified to prevent postoperative sleep disturbance. Dexmedetomidine induces a distinct sedative response, with a easy transition from sleep to wakefulness and deep sedation similar to natural sleep, while maintaining forebrain connectivity. This has clinical implications for reducing postoperative sleep disturbances by exploring optimal combinations of anaesthetic drugs.
In this study, all subjects meeting the inclusion criteria will be randomly assigned to one of three groups: Dexmedetomidine 0.2 ug/kg, Dexmedetomidine 0.5 ug/kg and normal saline as control group. All dexmedetomidine solutions were diluted to 0.6ml at different doses and prepared by a senior nurse who was not involved in the follow-up. All patients received no preoperative medication. On arrival in the waiting room, all patients were examined and received an intranasal spray of a total volume of 0.6ml 25 minutes before anesthesia. Patients, anesthetists, gynecologists and nurses were all blinded to group allocation. Patients received an intravenous cannula with lactated Ringer's solution. Heart rate, non-invasive blood pressure, electrocardiogram, and SpO2 and BIS were monitored during hysteroscopic procedures. Propofol was administered via the TCI infusion system using the Marsh pharmacokinetic parameters with a target plasma concentration of 3.2 ng/ml in three groups. The initial starting dose of propofol was based on the results of our pre-test and BIS. If the target was achieved and the BIS was <50, remifentanil was given at 1 ug/kg by pump and LMA was then placed. During the hysteroscopy, TCI was regulated according to the up and down method of Dixon, first described in 1965. TCI was upregulated by 0.1-0.2 when patients had a somatic response （unintended movement of the angelus orris or limbs） during cervical dilation. In the absence of limb movement, the subsequent target plasma concentration was reduced by 0.1 ng/ml. Emergency equipment and drugs were available at all times.
Early recovery will be evaluated in PACU and Later recovery will be measured using QoR-40 questionnaire. Sleep quality was monitored using a wearable device and assessed using the Pittsburgh Sleep Quality Index questionnaire 1-2 days before surgery and 1, 3, and 7 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Normal SalineNasal spray with nomal saline before anesthesia |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineNasal spray with dexmedetomidine before anesthesia |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.Patients undergoing hysteroscopy in the hospital;2. American Society of Anesthesiologists Classification (ASA) I-II;3.No significant cardiovascular disease, liver, and kidney function within normal limits;4.Fully informed about the study and willing to participate by signing the informed consent form.
Key exclusion criteria (1 listed)
- 1. ASA III-IV, severe cardiovascular disease, or poor physical condition;2. History of mental illness;3. History of sedative or antipsychotic drug use (neuroinhibitors, anxiolytics, antidepressants, benzodiazepines) for any reason;4. History of sleep disorders or have night shifts;5. Surgical complications (bleeding, reoperation, meningitis);6. Nasal deformity or nasal trauma.
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 |
|---|---|---|
| Normal SalineFemale patients undergoing hysteroscopy receive nasal spray with normal saline before anesthesia | Drug | Control |
| DexmedetomidineFemale patients undergoing hysteroscopy receive nasal spray with dexmedetomidine before anesthesia | Drug | Dexmedetomidine |
Primary outcome
Change from baseline sleep quality at after intervention
Time frame: 1-2 day before and 7 days after anesthesia exposure
Wearable devices continuously records Night sleep duration, deep sleep proportion, light sleep proportion, rapid eye movement (REM) proportion, deep sleep continuity, waking times, and breathing quality.All these parameters are registered and combined in a report that indicates the degree of quality of the person's sleep as good, fair or poor.
Pittsburgh sleep quality index(PSQI)
Time frame: 1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.
Total scores range from 0 to 21, with higher scores indicating worse sleep quality. PSQI≥8 was defined as sleep disorder.
2 secondary outcomes
Early recovery evaluated by Aldrete rating scale
Time frame: Post anesthesia care unit time
Later Recovery evaluated by QoR-40 questionnaire
Time frame: QoR-40 score on the third day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 34393534Wang X, Hua D, Tang X, Li S, Sun R, Xie Z, Zhou Z, Zhao Y, Wang J, Li S, Luo A. The Role of Perioperative Sleep Disturbance in Postoperative Neurocognitive Disorders. Nat Sci Sleep. 2021 Aug 6;13:1395-1410. doi: 10.2147/NSS.S320745. eCollection 2021.
- Background: PubMed 37718079Purcell KF, Scarcella N, Chun D, Holland C, Stauffer TP, Bolognesi M, Lachiewicz P. Treating Sleep Disorders After Total Hip and Total Knee Arthroplasty. Orthop Clin North Am. 2023 Oct;54(4):397-405. doi: 10.1016/j.ocl.2023.05.008. Epub 2023 Jul 11.
- Results publication: PubMed 36570021Yu S, Xiong Y, Lu G, Xiong X. Effects of Preoperative Sleep Disorders on Anesthesia Recovery and Postoperative Pain in Patients Undergoing Laparoscopic Gynecological Surgery under General Anesthesia. Mediators Inflamm. 2022 Dec 15;2022:7998104. doi: 10.1155/2022/7998104. eCollection 2022.
- Results publication: PubMed 37736695Jia X, Song Y, Li Z, Yang N, Liu T, Han D, Sun Z, Shi C, Zhou Y, Shi J, Liu Y, Guo X. Melatonin regulates the circadian rhythm to ameliorate postoperative sleep disorder and neurobehavioral abnormalities in aged mice. CNS Neurosci Ther. 2024 Mar;30(3):e14436. doi: 10.1111/cns.14436. Epub 2023 Sep 22.
- Results publication: PubMed 37550718Shi Y, Sun Q, Wang Y, Chen C, Jin J, Wang W, Lu Y, Hua Y, Liu J, Bian J, Yi Z. Can dexamethasone improve postoperative sleep and postoperative delirium in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy? Protocol for a prospective, randomized, double-blind, controlled study. Trials. 2023 Aug 8;24(1):505. doi: 10.1186/s13063-023-07521-8.
- Results publication: PubMed 34162157Zhang Y, Tan SL, Du J, Chen Y, Jia J, Feng JG, Liu KX, Zhou J. Dexmedetomidine alleviates neuroinflammation, restores sleep disorders and neurobehavioral abnormalities in rats with minimal hepatic encephalopathy. Int Immunopharmacol. 2021 Jul;96:107795. doi: 10.1016/j.intimp.2021.107795. Epub 2021 May 24.
- Results publication: PubMed 37544550De Zen L, Divisic A, Molinaro G, Solidoro S, Barbi E. Dexmedetomidine at Home for Intractable Dystonia and Insomnia in Children With Special Needs: A Case Series. J Pain Symptom Manage. 2023 Dec;66(6):e653-e657. doi: 10.1016/j.jpainsymman.2023.07.018. Epub 2023 Aug 5.
- Derived from this study: PubMed 41761098Wang L, Qiu G, Li X, Yang B. Intranasal low-dose dexmedetomidine alleviates propofol-associated postoperative sleep disturbance in female hysteroscopy patients: a randomized controlled trial. BMC Anesthesiol. 2026 Feb 27;26(1):213. doi: 10.1186/s12871-026-03720-3.
- Derived from this study: PubMed 39010171Li X, Yan L, Wang L, Chen H, Yang B. Study on the preventive effect of dexmedetomidine on anesthetic associated sleep disturbance in young to middle-aged female patients undergoing hysteroscopy: a study protocol for a crossover randomized controlled trial. Trials. 2024 Jul 15;25(1):480. doi: 10.1186/s13063-024-08311-6.
- Individual participant dataSharing planned: Yes. We expect to release the original data on the ResMan original data sharing platform （IPD sharing platform）.
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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.
BIN YANG principal investigator
The First Affiliated Hospital of Xiamen University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Normal Saline and Dexmedetomidine in people with Postoperative Sleep Disturbance, run by The First Affiliated Hospital of Xiamen University.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BIN YANG, Ph.D (+8613859986036, yangbin4332@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline sleep quality at after intervention (time frame: 1-2 day before and 7 days after anesthesia exposure). 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?
On the ClinicalTrials.gov record for NCT06281561, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.