Sleep DisorderPSQNCT06633432
Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery
A study testing Acupuncture in people with Sleep Disorder, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to to explore the effect of perioperative transcutaneous acupoint acupuncture and moxibustion stimulation on sleep quality and postoperative chronic pain in patients undergoing thoracoscopic assisted radical resection of lung cancer, and explore its potential mechanism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Dec 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Case selection: Patients undergoing elective thoracoscopic assisted radical resection for lung cancer, ASA grade I-II, aged 18-75 years.
- Hospitalized patients aged ≥ 18 years old;
- The surgical method is non emergency thoracoscopic assisted radical resection of lung cancer;
- Patients with normal mental state, able to understand NRS scores, and correctly assess the degree of pain;
- Patients who are informed and agree to the research objectives as explained.
- Body Mass Index (BMI) 18.5-28 kg/m2
- Preoperative clinical tumor lymph node metastasis (TNM) staging: according to cTis-3N01M0 of AJCC/UICC 8th edition.
Who cannot join
- Patients with critical preoperative conditions or inability to cooperate;
- Patients with postoperative disease recurrence, chronic infection, reoperation, or death;
- Patients with severe complications, critical illness, or inability to cooperate after surgery;
- Pittsburgh Sleep Quality Index (PSQI) score ≥ 7 or Insomnia Diagnosis - Ashens Insomnia Scale (AIS) score ≥ 6;
- Sleep apnea or moderate or severe snoring;
- In situ pacemaker, preoperative sinus bradycardia (heart rate ≤ 50 beats/minute) or sinoatrial node disease, second or third degree atrioventricular block
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- Long term use of anticonvulsants, antidepressants, or other psychotropic drugs
- Severely sensitive or allergic to the drugs or devices in this study
- Severe heart, liver, or kidney disease;
- Participated in other clinical trials within the past 3 months;
- Listening and/or language communication barriers; i) Pregnancy or breastfeeding; j) Clinical (hematological, radiological, and/or microbiological) evidence of fever (body temperature 38.5 ℃) or preoperative infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital
Shanghai, Shanghai Municipality, 201600
Shanghai1st, +86+21+63240090, shiyicss@126.com
About this study
The goal of this clinical trial is to to explore the effect of perioperative transcutaneous acupoint acupuncture and moxibustion stimulation on sleep quality and postoperative chronic pain in patients undergoing thoracoscopic assisted radical resection of lung cancer, and explore its potential mechanism. This clinical trial focus on the following questions:
Whether perioperative transcutaneous acupoint acupuncture and moxibustion stimulation reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain ? What medical problems do participants have when taking acupuncture? Researchers will compare acupuncture to sham acupuncture (Non transdermal comfort needles can cause patients to experience a needle like sensation; similar to when the needle is inserted into the skin, but in reality, it does not break the skin) to see if acupuncture works to reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain.
Read more
Participants will:
Take acupuncture or a sham acupuncture every day for 3 days(the night before surgery, the night of surgery and the first night after surgery).
On the day before surgery, the first day after surgery, the second day after surgery, and the day before discharge, the sleep status should be continuously monitored using a sleep monitoring screening device (ZG-S01D) The incidence of pain is determined by whether there is pain (including all discomfort) during patient follow-up.
Read the detailed description
This experiment is divided into two groups: the experimental group and the control group. If you participate in the experiment, you will be randomly assigned to two groups, with a 50% probability of entering the experimental group and a 50% probability of entering the control group.
Research steps Anesthesia process i. Preoperative preparation Complete the scoring form, continuous dynamic blood pressure monitoring, and continuous electrocardiogram monitoring 24 hours before surgery. All patients were fasted and deprived of water for 8 hours before surgery. The upper limb venous access was opened in the pre anesthesia room. Bupivacaine liposomes were used to block the intercostal nerves in 4 intercostal spaces above and below the incision, and invasive anesthesia was performed around the surgical incision and drainage tube placement. Supplement sodium lactate Ringer solution according to the preoperative loss amount. Confirm the informed consent status again.
After entering the room, routine electrocardiographic monitoring (ECG), non-invasive arterial blood pressure (NIBP), oxygen saturation (SpO2), and mask oxygen inhalation were performed.
ii. Anesthesia induction and maintenance Anesthesia induction: Inject sufentanil 0.4ug/kg and propofol 1.5-2mg/ml intravenously in sequence. After the patient's consciousness disappears, inject rocuronium 0.6mg/kg intravenously, insert a double lumen bronchial tube (F35-37), and locate with a fiberoptic bronchoscope.
Anesthesia maintenance: maintained by inhalation of sevoflurane, intraoperative detection of end tidal sevoflurane MAC value, maintained at 1.0-1.2MAC; Administer sufentanil and rocuronium bromide intravenously as needed during surgery.
Anesthesia recovery: The patient is transferred to the post anesthesia care unit (PACU) after conscious extubation, and then transferred to the ward to ensure complete consciousness. The Aldrete score is ≥ 9.
Treatment and follow-up process i. The acupuncture group administered medication three times at each acupoint: (1) the night before surgery, (2) the night of surgery, and (3) the first night after surgery. Acupuncture and moxibustion stimulation is applied to four pairs of acupoints: bilateral Shenmen (HT7), Neiguan (PC6), Zusanli (ST36) and Zhaohai (KI6), which are selected according to the previous systematic review and the summary of clinical experience . The pillow used is a disposable, sterile, stainless steel needle with a length of 40mm and a diameter of 0.25mm. In the acupuncture group, the acupuncture and moxibustion successively acupunctured four points with a depth of 10-20mm. Select the specific depth based on the subject's body type (tall, short, fat, thin). After the puncture, the acupuncture and moxibustion lifted and twisted the needle handle, and then retained the needle for 20 minutes. The sham acupuncture group received non skin breaking comfort needles at corresponding points for acupuncture and moxibustion the night before the operation, the night of the operation and the first night after the operation, and kept the needles for 20 minutes. Non transdermal comfort needles can cause patients to experience a needle like sensation similar to piercing the skin, but in reality, they do not break the skin. Before each application of acupuncture, it is necessary to evaluate whether the patient can perform acupuncture and moxibustion and whether there is a history of fainting. If there is a history of needle dizziness, the trial must be withdrawn.
ii. On the day before surgery, the first day after surgery, the second day, and the day before discharge, the sleep status should be continuously monitored using a sleep monitoring screening device (ZG-S01D).
iii. The degree of postoperative acute pain mainly includes the pain during rest, activity, and coughing on the first to seventh day after surgery or during hospitalization (when hospitalization days are less than 7 days). The evaluation time point is twice a day (9am and 3pm) on postoperative days 1-2; From the 3rd to the 7th day after surgery, once a day (9am). Pain description and the impact of pain on body function should be evaluated once on the 7th day after surgery or discharge day. In addition, on the first day after surgery at 9am, patients were also asked to recall the most severe resting pain level after surgery; The degree of pain within 24 hours after surgery (1 hour, 4 hours, 8 hours, and 16 hours) is indirectly reflected by heart rate, blood pressure, and blood oxygen saturation (medical record review). The severity of postoperative acute pain in patients is mainly obtained by researchers through face-to-face pain assessment, with the assistance of nurses if necessary.
iiii. Postoperative chronic pain (CPSP) of patients and pain during follow-up include four aspects: pain incidence, pain description, pain severity, and the impact of pain on body function. The evaluation is mainly conducted by researchers through telephone follow-up, with evaluation times of 2 weeks, 1 month, 2 months, 3 months, and 6 months after surgery, respectively. The pain followed up at 3 months after surgery is postoperative chronic pain.
If you agree to participate in this study, please sign this informed consent form. During the entire study period, it is planned to collect 5 additional blood samples, each containing 5ml, with a total volume of approximately 25ml, for the determination of serum levels of IL-1, IL-6, TNF - α, plasma levels of 5-HT, DA, NE, and melatonin.
- Conditions
- Sleep Disorder
- Being tested
- Acupuncture, Sham-acupuncture stimulation
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Administer medication at each acupoint a total of three times: (1) the night before surgery, (2) the night of surgery, and (3) the first night after surgery. In the acupuncture group, the acupuncture and moxibustion successively acupunctured four points with a depth of 10-20mm. Select the specific depth based on the subject\'s body type (tall, short, fat, thin). After the puncture, the acupuncture and moxibustion lifted and twisted the needle handle, and then retained the needle for 20 minutes.
Sham-acupuncture stimulationOther
Also called sham acupuncture
The sham acupuncture group received non skin breaking comfort needles at the corresponding points for acupuncture and moxibustion and retained the needles for 20 minutes. Non transdermal comfort needles can cause patients to experience a needle like sensation similar to piercing the skin, but in reality, they do not break the skin.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | The acupuncture group administered medication three times at each acupoint: (1) the night before surgery, (2) the night of surgery, and (3) the first night after surgery. Acupuncture and moxibustion stimulation was applied to four pairs of acupoints: bilateral Shenmen (HT7), Neiguan (PC6), Zusanli (ST36) and Zhaohai (KI6), and the penetration depth was 10-20mm. Select the specific depth based on the subject's body type (tall, short, fat, thin). After the puncture, the acupuncture and moxibustion lifted and twisted the needle handle, and then retained the needle for 20 minutes. Receives: Other: Acupuncture |
| Sham-acupuncture group | Sham comparator | The sham acupuncture group received non skin breaking comfort needles at corresponding points for acupuncture and moxibustion the night before the operation, the night of the operation and the first night after the operation, and kept the needles for 20 minutes. Non transdermal comfort needles can cause patients to experience a "needle like sensation" similar to piercing the skin, but in reality, they do not break the skin. Receives: Other: Sham-acupuncture stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Postoperative Sleep Disorders as Assessed by sleep monitoring screening device (ZG-S01D) and The The Athens Insomnia Scale
The Athens Insomnia Scale (AIS) is a self-assessment scale designed based on the ICD-10 diagnostic criteria for insomnia. There are a total of 8 questions, with the first 5 questions evaluating nighttime sleep and the last 3 questions evaluating daytime function. The scoring range for each question is 0-3, with a total score of 24 points. A score greater than or equal to 6 indicates the presence of sleep disorders. AIS is suitable for evaluating sleep status in the past month.
Measured: From enrollment to the end of treatment at 1 week;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start31 Dec 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIna Huang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Shanghai 1st, Study director, Xueying Ding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633432
- Sponsor's protocol ID
- Yuan Lun Shen 【2024】No.164
- Acronym
- PSQ
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT06633432
- Acronym / sponsor ID
- PSQ / Yuan Lun Shen 【2024】No.164
- Conditions
- Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Oct 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 to explore the effect of perioperative transcutaneous acupoint acupuncture and moxibustion stimulation on sleep quality and postoperative chronic pain in patients undergoing thoracoscopic assisted radical resection of lung cancer, and explore its potential mechanism. This clinical trial focus on the following questions:
Whether perioperative transcutaneous acupoint acupuncture and moxibustion stimulation reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain ? What medical problems do participants have when taking acupuncture? Researchers will compare acupuncture to sham acupuncture (Non transdermal comfort needles can cause patients to experience a needle like sensation; similar to when the needle is inserted into the skin, but in reality, it does not break the skin) to see if acupuncture works to reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain.
Participants will:
Take acupuncture or a sham acupuncture every day for 3 days(the night before surgery, the night of surgery and the first night after surgery).
On the day before surgery, the first day after surgery, the second day after surgery, and the day before discharge, the sleep status should be continuously monitored using a sleep monitoring screening device (ZG-S01D) The incidence of pain is determined by whether there is pain (including all discomfort) during patient follow-up.
Detailed description
This experiment is divided into two groups: the experimental group and the control group. If you participate in the experiment, you will be randomly assigned to two groups, with a 50% probability of entering the experimental group and a 50% probability of entering the control group.
Research steps Anesthesia process i. Preoperative preparation Complete the scoring form, continuous dynamic blood pressure monitoring, and continuous electrocardiogram monitoring 24 hours before surgery. All patients were fasted and deprived of water for 8 hours before surgery. The upper limb venous access was opened in the pre anesthesia room. Bupivacaine liposomes were used to block the intercostal nerves in 4 intercostal spaces above and below the incision, and invasive anesthesia was performed around the surgical incision and drainage tube placement. Supplement sodium lactate Ringer solution according to the preoperative loss amount. Confirm the informed consent status again.
After entering the room, routine electrocardiographic monitoring (ECG), non-invasive arterial blood pressure (NIBP), oxygen saturation (SpO2), and mask oxygen inhalation were performed.
ii. Anesthesia induction and maintenance Anesthesia induction: Inject sufentanil 0.4ug/kg and propofol 1.5-2mg/ml intravenously in sequence. After the patient's consciousness disappears, inject rocuronium 0.6mg/kg intravenously, insert a double lumen bronchial tube (F35-37), and locate with a fiberoptic bronchoscope.
Anesthesia maintenance: maintained by inhalation of sevoflurane, intraoperative detection of end tidal sevoflurane MAC value, maintained at 1.0-1.2MAC; Administer sufentanil and rocuronium bromide intravenously as needed during surgery.
Anesthesia recovery: The patient is transferred to the post anesthesia care unit (PACU) after conscious extubation, and then transferred to the ward to ensure complete consciousness. The Aldrete score is ≥ 9.
Treatment and follow-up process i. The acupuncture group administered medication three times at each acupoint: (1) the night before surgery, (2) the night of surgery, and (3) the first night after surgery. Acupuncture and moxibustion stimulation is applied to four pairs of acupoints: bilateral Shenmen (HT7), Neiguan (PC6), Zusanli (ST36) and Zhaohai (KI6), which are selected according to the previous systematic review and the summary of clinical experience . The pillow used is a disposable, sterile, stainless steel needle with a length of 40mm and a diameter of 0.25mm. In the acupuncture group, the acupuncture and moxibustion successively acupunctured four points with a depth of 10-20mm. Select the specific depth based on the subject's body type (tall, short, fat, thin). After the puncture, the acupuncture and moxibustion lifted and twisted the needle handle, and then retained the needle for 20 minutes. The sham acupuncture group received non skin breaking comfort needles at corresponding points for acupuncture and moxibustion the night before the operation, the night of the operation and the first night after the operation, and kept the needles for 20 minutes. Non transdermal comfort needles can cause patients to experience a needle like sensation similar to piercing the skin, but in reality, they do not break the skin. Before each application of acupuncture, it is necessary to evaluate whether the patient can perform acupuncture and moxibustion and whether there is a history of fainting. If there is a history of needle dizziness, the trial must be withdrawn.
ii. On the day before surgery, the first day after surgery, the second day, and the day before discharge, the sleep status should be continuously monitored using a sleep monitoring screening device (ZG-S01D).
iii. The degree of postoperative acute pain mainly includes the pain during rest, activity, and coughing on the first to seventh day after surgery or during hospitalization (when hospitalization days are less than 7 days). The evaluation time point is twice a day (9am and 3pm) on postoperative days 1-2; From the 3rd to the 7th day after surgery, once a day (9am). Pain description and the impact of pain on body function should be evaluated once on the 7th day after surgery or discharge day. In addition, on the first day after surgery at 9am, patients were also asked to recall the most severe resting pain level after surgery; The degree of pain within 24 hours after surgery (1 hour, 4 hours, 8 hours, and 16 hours) is indirectly reflected by heart rate, blood pressure, and blood oxygen saturation (medical record review). The severity of postoperative acute pain in patients is mainly obtained by researchers through face-to-face pain assessment, with the assistance of nurses if necessary.
iiii. Postoperative chronic pain (CPSP) of patients and pain during follow-up include four aspects: pain incidence, pain description, pain severity, and the impact of pain on body function. The evaluation is mainly conducted by researchers through telephone follow-up, with evaluation times of 2 weeks, 1 month, 2 months, 3 months, and 6 months after surgery, respectively. The pain followed up at 3 months after surgery is postoperative chronic pain.
If you agree to participate in this study, please sign this informed consent form. During the entire study period, it is planned to collect 5 additional blood samples, each containing 5ml, with a total volume of approximately 25ml, for the determination of serum levels of IL-1, IL-6, TNF - α, plasma levels of 5-HT, DA, NE, and melatonin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: AcupunctureThe acupuncture group administered medication three times at each acupoint: (1) the night before surgery, (2) the night of surgery, and (3) the first night after surgery. Acupuncture and moxibustion stimulation was applied to four pairs of acupoints: bilateral Shenmen (HT7), Neiguan (PC6), Zusanli (ST36) and Zhaohai (KI6), and the penetration depth was 10-20mm. Select the specific depth based on the subject's body type (tall, short, fat, thin). After the puncture, the acupuncture and moxibustion lifted and twisted the needle handle, and then retained the needle for 20 minutes. |
| Sham-acupuncture group | Sham comparator | Other: Sham-acupuncture stimulationThe sham acupuncture group received non skin breaking comfort needles at corresponding points for acupuncture and moxibustion the night before the operation, the night of the operation and the first night after the operation, and kept the needles for 20 minutes. Non transdermal comfort needles can cause patients to experience a "needle like sensation" similar to piercing the skin, but in reality, they do not break the skin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Case selection: Patients undergoing elective thoracoscopic assisted radical resection for lung cancer, ASA grade I-II, aged 18-75 years.
- Hospitalized patients aged ≥ 18 years old;
- The surgical method is non emergency thoracoscopic assisted radical resection of lung cancer;
- Patients with normal mental state, able to understand NRS scores, and correctly assess the degree of pain;
- Patients who are informed and agree to the research objectives as explained.
Key exclusion criteria (11 listed)
- Patients with critical preoperative conditions or inability to cooperate;
- Patients with postoperative disease recurrence, chronic infection, reoperation, or death;
- Patients with severe complications, critical illness, or inability to cooperate after surgery;
- Pittsburgh Sleep Quality Index (PSQI) score ≥ 7 or Insomnia Diagnosis - Ashens Insomnia Scale (AIS) score ≥ 6;
- Sleep apnea or moderate or severe snoring;
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 |
|---|---|---|
| AcupunctureAdminister medication at each acupoint a total of three times: (1) the night before surgery, (2) the night of surgery, and (3) the first night after surgery. In the acupuncture group, the acupuncture and moxibustion successively acupunctured four points with a depth of 10-20mm. Select the specific depth based on the subject\'s body type (tall, short, fat, thin). After the puncture, the acupuncture and moxibustion lifted and twisted the needle handle, and then retained the needle for 20 minutes. | Other | Acupuncture group |
| Sham-acupuncture stimulationAlso: sham acupunctureThe sham acupuncture group received non skin breaking comfort needles at the corresponding points for acupuncture and moxibustion and retained the needles for 20 minutes. Non transdermal comfort needles can cause patients to experience a needle like sensation similar to piercing the skin, but in reality, they do not break the skin. | Other | Sham-acupuncture group |
Primary outcome
The incidence of Postoperative Sleep Disorders as Assessed by sleep monitoring screening device (ZG-S01D) and The The Athens Insomnia Scale
Time frame: From enrollment to the end of treatment at 1 week;
The Athens Insomnia Scale (AIS) is a self-assessment scale designed based on the ICD-10 diagnostic criteria for insomnia. There are a total of 8 questions, with the first 5 questions evaluating nighttime sleep and the last 3 questions evaluating daytime function. The scoring range for each question is 0-3, with a total score of 24 points. A score greater than or equal to 6 indicates the presence of sleep disorders. AIS is suitable for evaluating sleep status in the past month.
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 Oct 2024.
- 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.
Shanghai 1st study director
Xueying Ding
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Sleep Disorder, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 11 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 Oct 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. 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 Lina Huang N Huang (86-021-63240090, shiyicss@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Postoperative Sleep Disorders as Assessed by sleep monitoring screening device (ZG-S01D) and The The Athens Insomnia Scale (time frame: From enrollment to the end of treatment at 1 week;). 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 Oct 2024.