Primary InsomniaNCT05830877
The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia
A study testing the acupuncture group in people with Primary Insomnia, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- the acupuncture group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2023to 31 Dec 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;
- Age range: 18-70 years old;
- PSQI score>7 points; SAS score > 50 or SDS score > 53;
- No communication and cognitive impairment;
- No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases;
- Those who voluntarily accept the research content and can complete various scale evaluations, polysomnography monitoring and HRV;
- Sign an informed consent form prior to the start of the study.
Who cannot join
- Those who do not meet the inclusion criteria;
- Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;
- Those with severe liver and renal insufficiency and bleeding tendencies;
- Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs;
- People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders;
- Pregnant or nursing;
- Those with other major diseases and poor control;
- Other persons who are unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Yingjun Liu, Doctor, 15958033054, 20185003@zcmu.edu.cn
About this study
Official title: The RCT Study on the Evaluation of Clinical Effect of Primary Insomnia Treated With the Tiaoshen Acupuncture
Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.
- Conditions
- Primary Insomnia
- Being tested
- the acupuncture group, the placebo acupuncture group
- Keywords
- acupuncture, Primary Insomnia, RCT
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the acupuncture groupOther
The primary choice is to puncture GB20 with a quick puncture, which means "regulate the mind and open the way". ①Scalp acupuncture: Du 20(Baihui), EX-HN 3(Yintang), EX-HNl(Sishencong); ②Select acupoints from six acupoints for mind-regulating, ear points (both sides): heart, lung, and Shenmen; body points (both sides): LI20(Yingxiang), EXTRA 12(Anmian), ST36(Zusanli) as the main hole. ③Sleeping three needles(both sides): HT7(Shenmen), PC6(Neiguan), SP6(Sanyinjiao); ④Opening four gates: LI4(Hegu) , LR3(Taichong) ⑤Abdominal four needles:ST25(Tianshu), CV12(Zhongwan), CV4(Guanyuan). For body acupuncture, a 0.3 mm×40 mm needle was used to insert directly for 0.5-1.0 cun, and twisting to gain the qi; for auricular points, a 0.25 mm×40 mm needle was used for 2-3 minutes without manipulating the needle. The acupuncture points were retained for 30 min, and the treatment was performed once every other day, three times a week, and the curative effect was evaluated after 4 weeks of treatment.
the placebo acupuncture groupOther
Subjects in the placebo acupuncture group will receive non-insertive acupuncture using the sham needle supported by the Park device. This needle has a retractable shaft and a blunt tip, they could not penetrate the skin. We gently placed the sham needle and Park device on the skin. The sham needle is then no longer manipulated to minimize any physiological effects. The selected acupoints and needle retention time were the same as for the acupuncture group. Since oblique insertion is required for acupuncture points on the head, the fixed acupuncture body of the Park device could not be used. Therefore, blunt needles are used to stimulate the head points to reduce the amount of stimulation produced by acupuncture. At the end of the treatment, the acupuncturist also used a dry cotton swab to press the acupoints so that patients could feel the withdrawal of 'real' needles.
| Study group | Role | What they receive |
|---|---|---|
| the acupuncture group | Experimental | the patients included in this arm will recept the Tiaoshen acupuncture. Receives: Other: the acupuncture group |
| the placebo acupuncture group | Active comparator | Subjects in the placebo acupuncture group will receive non-insertive acupuncture using the sham needle supported by the Park device, and the selected acupoints is the same as the acupuncture group. Receives: Other: the placebo acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Measured: Before treatment
Pittsburgh sleep quality index
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Measured: the 4th week of treatment
Pittsburgh sleep quality index
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data.The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Measured: 4 weeks after treatment
Secondary outcomes (14)
Fatigue Scale-14
Respond to the severity of fatigue from different angles through 14 questions.The Fatigue Scale-14 is composed of 14 items, and the 14 items are divided into two categories. One category reflects physical fatigue, including 1 to 8 items; the other reflects mental fatigue, including 9 to 14 in total 6 items. The highest score for physical fatigue is 8, the highest score for mental fatigue is 6, and the highest total score is 14. The higher the score, the more severe the fatigue.
Measured: Before treatment
Fatigue Scale-14
Respond to the severity of fatigue from different angles through 14 questions.The Fatigue Scale-14 is composed of 14 items, and the 14 items are divided into two categories. One category reflects physical fatigue, including 1 to 8 items; the other reflects mental fatigue, including 9 to 14 in total 6 items. The highest score for physical fatigue is 8, the highest score for mental fatigue is 6, and the highest total score is 14. The higher the score, the more severe the fatigue.
Measured: the 4th week of treatment
Fatigue Scale-14
Respond to the severity of fatigue from different angles through 14 questions.The Fatigue Scale-14 is composed of 14 items, and the 14 items are divided into two categories. One category reflects physical fatigue, including 1 to 8 items; the other reflects mental fatigue, including 9 to 14 in total 6 items. The highest score for physical fatigue is 8, the highest score for mental fatigue is 6, and the highest total score is 14. The higher the score, the more severe the fatigue.
Measured: 4 weeks after treatment
Epworth Sleepiness Scale
The epworth sleepiness scale is applied to assess excessive daytime sleepiness. The clinical significance of this table is: sleepiness can be semi-objectively assessed by the epworth sleepiness scale. Any sleep disorder caused by sleep deprivation may lead to change of this scale. This scale has 24 points. A score greater than 6 indicates drowsiness, a score greater than 11 indicates excessive sleepiness, and a score greater than 16 indicates dangerous drowsiness.
Measured: Before treatment
Epworth Sleepiness Scale
The epworth sleepiness scale is applied to assess excessive daytime sleepiness. The clinical significance of this table is: sleepiness can be semi-objectively assessed by the epworth sleepiness scale. Any sleep disorder caused by sleep deprivation may lead to change of this scale. This scale has 24 points. A score greater than 6 indicates drowsiness, a score greater than 11 indicates excessive sleepiness, and a score greater than 16 indicates dangerous drowsiness.
Measured: he 4th week of treatment
Epworth Sleepiness Scale
The epworth sleepiness scale is applied to assess excessive daytime sleepiness. The clinical significance of this table is: sleepiness can be semi-objectively assessed by the epworth sleepiness scale. Any sleep disorder caused by sleep deprivation may lead to change of this scale. This scale has 24 points. A score greater than 6 indicates drowsiness, a score greater than 11 indicates excessive sleepiness, and a score greater than 16 indicates dangerous drowsiness.
Measured: 4 weeks after treatment
Self-Rating Anxiety Scale
SAS is called anxiety self-rating scale, which is a standard for anxiety assessment and a psychological scale used to measure the degree of anxiety state and its changes during treatment. The SAS scale has 100 points in total, and the cut-off value is 50 points, of which 50-59 points are mild anxiety, 60-69 points are moderate anxiety, and more than 70 points are severe anxiety.
Measured: Before treatment
Self-Rating Anxiety Scale
SAS is called anxiety self-rating scale, which is a standard for anxiety assessment and a psychological scale used to measure the degree of anxiety state and its changes during treatment. The SAS scale has 100 points in total, and the cut-off value is 50 points, of which 50-59 points are mild anxiety, 60-69 points are moderate anxiety, and more than 70 points are severe anxiety.
Measured: 4th week of treatment
Self-Rating Anxiety Scale
SAS is called anxiety self-rating scale, which is a standard for anxiety assessment and a psychological scale used to measure the degree of anxiety state and its changes during treatment. The SAS scale has 100 points in total, and the cut-off value is 50 points, of which 50-59 points are mild anxiety, 60-69 points are moderate anxiety, and more than 70 points are severe anxiety.
Measured: 4 weeks after treatment
Self-rating depression scale
The depression self-rating scale is a standard for depression assessment, which can quite intuitively reflect the subjective feelings of depressed patients during treatment. It is mainly applicable to adults with depressive symptoms, including outpatients and inpatients. The SDS scale has 100 points in total, and the cut-off value is 53 points, of which 53-62 points are mild anxiety, 63-72 points are moderate anxiety, and more than 73 points are severe anxiety.
Measured: Before treatment
Self-rating depression scale
The depression self-rating scale is a standard for depression assessment, which can quite intuitively reflect the subjective feelings of depressed patients during treatment. It is mainly applicable to adults with depressive symptoms, including outpatients and inpatients. The SDS scale has 100 points in total, and the cut-off value is 53 points, of which 53-62 points are mild anxiety, 63-72 points are moderate anxiety, and more than 73 points are severe anxiety.
Measured: the 4th week of treatment
Self-rating depression scale
The depression self-rating scale is a standard for depression assessment, which can quite intuitively reflect the subjective feelings of depressed patients during treatment. It is mainly applicable to adults with depressive symptoms, including outpatients and inpatients. The SDS scale has 100 points in total, and the cut-off value is 53 points, of which 53-62 points are mild anxiety, 63-72 points are moderate anxiety, and more than 73 points are severe anxiety.
Measured: 4 weeks after treatment
Polysomnography
Polysomnography refers to the continuous and synchronous acquisition, recording and analysis of EEG, electrooculogram, electromyogram, oronasal airflow, respiratory effort, and saturation of oxygen levels, body position and other physiological and pathological parameters during sleep by sleep technicians all night through computer software in the sleep laboratory. This technology for the diagnosis of sleep disorders is the gold standard for the diagnosis and treatment of sleep disorders.
Measured: the 4th week of treatment
Heart rate variability
Heart rate variability (HRV) refers to the fluctuations in the interval between successive heartbeats. It is commonly used to evaluate the regulatory role of the autonomic nervous system on cardiac activity. It is an important noninvasive indicator for evaluating autonomic nervous activity, and is also one of the important indicators for evaluating autonomic nervous changes during sleep.
Measured: the 4th week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start10 May 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Yingjun, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830877
- Sponsor's protocol ID
- 2023ZL476
- Status last verified
- Jun 2024
- First submitted
- 1 Apr 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RCT Study on the Evaluation of Clinical Effect of Primary Insomnia Treated With the Tiaoshen Acupuncture
- ClinicalTrials.gov ID
- NCT05830877
- Acronym / sponsor ID
- 2023ZL476
- Conditions
- Primary Insomnia
- Keywords
- acupuncture, Primary Insomnia, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Apr 2023 (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.
Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the acupuncture group | Experimental | Other: the acupuncture groupthe patients included in this arm will recept the Tiaoshen acupuncture. |
| the placebo acupuncture group | Active comparator | Other: the placebo acupuncture groupSubjects in the placebo acupuncture group will receive non-insertive acupuncture using the sham needle supported by the Park device, and the selected acupoints is the same as the acupuncture group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;
- Age range: 18-70 years old;
- PSQI score>7 points; SAS score > 50 or SDS score > 53;
- No communication and cognitive impairment;
- No use or withdrawal of psychoactive drugs such as anti-anxiety within one month; ·No major physical diseases;
Key exclusion criteria (8 listed)
- Those who do not meet the inclusion criteria;
- Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;
- Those with severe liver and renal insufficiency and bleeding tendencies;
- Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs;
- People with other sleep disorders, such as sleep apnea hypopnea syndrome, paroxysmal sleeping sickness, and REM sleep behavioral disorders;
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 |
|---|---|---|
| the acupuncture groupThe primary choice is to puncture GB20 with a quick puncture, which means "regulate the mind and open the way". ①Scalp acupuncture: Du 20(Baihui), EX-HN 3(Yintang), EX-HNl(Sishencong); ②Select acupoints from six acupoints for mind-regulating, ear points (both sides): heart, lung, and Shenmen; body points (both sides): LI20(Yingxiang), EXTRA 12(Anmian), ST36(Zusanli) as the main hole. ③Sleeping three needles(both sides): HT7(Shenmen), PC6(Neiguan), SP6(Sanyinjiao); ④Opening four gates: LI4(Hegu) , LR3(Taichong) ⑤Abdominal four needles:ST25(Tianshu), CV12(Zhongwan), CV4(Guanyuan). For body acupuncture, a 0.3 mm×40 mm needle was used to insert directly for 0.5-1.0 cun, and twisting to gain the qi; for auricular points, a 0.25 mm×40 mm needle was used for 2-3 minutes without manipulating the needle. The acupuncture points were retained for 30 min, and the treatment was performed once every other day, three times a week, and the curative effect was evaluated after 4 weeks of treatment. | Other | the acupuncture group |
| the placebo acupuncture groupSubjects in the placebo acupuncture group will receive non-insertive acupuncture using the sham needle supported by the Park device. This needle has a retractable shaft and a blunt tip, they could not penetrate the skin. We gently placed the sham needle and Park device on the skin. The sham needle is then no longer manipulated to minimize any physiological effects. The selected acupoints and needle retention time were the same as for the acupuncture group. Since oblique insertion is required for acupuncture points on the head, the fixed acupuncture body of the Park device could not be used. Therefore, blunt needles are used to stimulate the head points to reduce the amount of stimulation produced by acupuncture. At the end of the treatment, the acupuncturist also used a dry cotton swab to press the acupoints so that patients could feel the withdrawal of 'real' needles. | Other | the placebo acupuncture group |
Primary outcome
Pittsburgh sleep quality index
Time frame: Before treatment
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Pittsburgh sleep quality index
Time frame: the 4th week of treatment
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data. The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
Pittsburgh sleep quality index
Time frame: 4 weeks after treatment
Use the PSQI score table to evaluate according to patient's situation, and analyze the score changes of the subjects' insomnia degree before and after treatment by the analysis of score data.The PSQI consists of 19 self-rated questions and 5 questions rated by sleep partners. The 19 self-assessment questions constitute 7 factors ranging from 0 to 3 points. The cumulative score of each factor component is the total score of the PSQI, and the total score ranges from 0 to 21. The higher the score, the worse the sleep quality.
14 secondary outcomes
Fatigue Scale-14
Time frame: Before treatment
Fatigue Scale-14
Time frame: the 4th week of treatment
Fatigue Scale-14
Time frame: 4 weeks after treatment
Epworth Sleepiness Scale
Time frame: Before treatment
Epworth Sleepiness Scale
Time frame: he 4th week of treatment
Epworth Sleepiness Scale
Time frame: 4 weeks after treatment
Self-Rating Anxiety Scale
Time frame: Before treatment
Self-Rating Anxiety Scale
Time frame: 4th week of treatment
Self-Rating Anxiety Scale
Time frame: 4 weeks after treatment
Self-rating depression scale
Time frame: Before treatment
Self-rating depression scale
Time frame: the 4th week of treatment
Self-rating depression scale
Time frame: 4 weeks after treatment
Polysomnography
Time frame: the 4th week of treatment
Heart rate variability
Time frame: the 4th week of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the acupuncture group in people with Primary Insomnia, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
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 7 inclusion and 8 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 14 Jun 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingjun Liu, DR. (15958033054, frankly120@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index (time frame: Before treatment). The study lists 3 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 14 Jun 2024.