Sleep and Circadian ProblemsNCT07863804
Perioperative Sleep Recovery Trajectories in Patients of Different Sexes Undergoing Laparoscopic Cholecystectomy
An observational study of Sleep and Circadian Problems, run by Li Juan.
Trial summary
This is an observational clinical study. It does not give new treatments to participants. Researchers want to learn how sleep gets better or worse after laparoscopic gallbladder removal surgery. Sleep problems are common after surgery. Some people may recover their sleep faster than others. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep and Circadian Problems
- What is being tested?
- No study intervention
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 30 Dec 2026
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a prospective observational study designed to compare the recovery trajectories of perioperative stress-related sleep disturbances between male and female patients undergoing laparoscopic cholecystectomy. All enrolled participants will be naturally assigned to either the female group or the male group according to sex, without any study-related intervention.
Who may be able to join
- Aged 18-65 years of both genders. Alert and capable of normal communication. Voluntarily sign informed consent, complete the whole experimental procedure, and meet ethical and compliance requirements.
- Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia.
- No history of severe needle or blood phobia, and able to tolerate repeated venous blood sampling during the perioperative period.
- No long-term use of sedative-hypnotics, anxiolytics, antidepressants, or glucocorticoids within the past month, except for short-term use for acute illness for no more than 3 days; no other interventions that may affect sleep, such as transcranial magnetic stimulation or cognitive behavioral therapy.
- Stable vital signs, essentially normal function of major organs, including the heart, brain, lungs, liver, and kidneys, and no severe organic disease; able to tolerate surgery and the study procedures.
- Able to strictly follow the required sleep-wake schedule during the study period and cooperate with completion of sleep diaries, questionnaires, and all assessments, with good compliance.
Who cannot join
- 1: Aged <18 years or >65 years; pregnant or breastfeeding women; patients with psychiatric disorders, such as schizophrenia, mania, or depression, cognitive impairment, or inability to cooperate with the study, in order to avoid missing data or study bias due to poor cooperation.
- 2: Severe coagulation disorders, skin infection at the puncture site, or other conditions unsuitable for repeated blood sampling, to ensure the safety of blood collection procedures.
- 3: Use of sedative-hypnotics, anxiolytics, antidepressants, hormonal medications, or other sleep-related interventions within the past month that may affect the study outcomes, in order to minimize confounding factors and ensure the accuracy of the results.
- 4: Severe cardiovascular or cerebrovascular disease, severe hepatic or renal insufficiency, severe respiratory disease, or other conditions that may affect perioperative recovery or sleep assessment.
- 5: Major surgery or severe trauma within the past 3 months that may interfere with the perioperative stress response.
- 6: Alcohol or drug dependence, or consumption of more than three cups of coffee, strong tea, or other stimulant beverages per day with an inability to maintain relatively stable consumption habits during the study period, as substances such as caffeine may interfere with sleep.
- 7: Voluntary withdrawal from the study before completion, or inability to complete the study due to adverse reactions, poor compliance, or other reasons.
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: A Prospective Observational Study of Perioperative Sleep Recovery Trajectories in Patients of Different Sexes Undergoing Laparoscopic Cholecystectomy
This is an observational clinical study. It does not give new treatments to participants. Researchers want to learn how sleep gets better or worse after laparoscopic gallbladder removal surgery. Sleep problems are common after surgery. Some people may recover their sleep faster than others. Researchers will look at whether sleep recovery differs between women and men. They will also check how sex-related hormone levels connect with sleep changes.
About 58 participants will join this study.
Read more
Key requirements to take part:
- Aged 18 to 65 years old
- Scheduled for laparoscopic gallbladder removal under general anesthesia
- Able to give informed consent and finish all study tasks
- Can tolerate repeated blood draws
- No long-term sleep-affecting medicine use in the past one month
- Major organs work normally
People cannot join if they:
- Are younger than 18 years or older than 65 years
- Are pregnant or breastfeeding
- Have mental health or cognitive conditions that stop study participation
- Have problems that make repeated blood collection unsafe
- Have severe organ diseases or recent major injury or surgery
- Have alcohol or drug dependence
What happens for each participant:
- Before surgery: Participants sign consent forms. Staff collect basic health information. Participants wear a sleep-recording device called polysomnography (PSG) overnight. Participants fill out a short sleep diary each morning. Fasting blood samples are collected the next morning to measure hormone levels.
- On surgery day: Standard hospital care goes forward. Staff record surgery-related information. PSG sleep recording, sleep diary, and morning blood draw are repeated.
- First and second days after surgery: The same sleep recording, sleep diary, and morning fasting blood collection continue for two more nights.
Researchers compare sleep measurements across four nights. These measurements come from both PSG machine readings and participants' self-reported sleep diaries. Researchers also compare hormone level changes between female and male participants.
Possible benefits: Participants receive objective feedback on their own sleep and hormone results. If test values show clear concerns, researchers share these findings with their clinical care team. No direct treatment benefit is guaranteed.
Possible risks: This is a low-risk study. Small risks may include mild pain, bruising at blood draw sites, or temporary light-headedness from blood collection. Filling out short diaries may bring minor tiredness. All personal data will be kept private. Participants can leave the study at any time with no penalty.
- Conditions
- Sleep and Circadian Problems
- Being tested
- No study intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study interventionOther
This is a retrospective observational study based on existing medical records. No intervention, treatment, or procedure is assigned or administered by the study investigators. All data are collected retrospectively from routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| man group | No study intervention Receives: Other: No study intervention | |
| woman group | No study intervention Receives: Other: No study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wake After Sleep Onset (WASO), measured in minutes by polysomnography
Wake after sleep onset (WASO) is defined as the total amount of time spent awake after initial sleep onset and before final awakening during the monitoring period. WASO will be measured in minutes using polysomnography (PSG). A higher WASO indicates a greater amount of wakefulness during the sleep period.
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Proportions of Rapid Eye Movement (REM) Sleep, Non-Rapid Eye Movement (NREM) Sleep, and Wakefulness measured by polysomnography
Sleep and wake states will be determined using polysomnography (PSG). The proportions of rapid eye movement (REM) sleep, non-rapid eye movement (NREM) sleep, and wakefulness will be calculated as the percentage of the total recording time spent in each state. Values will be reported as percentages (%), with higher values indicating a greater proportion of the recording period spent in the corresponding state.
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Proportions of N1, N2, and N3 stages of non-rapid eye movement (NREM) sleep measured by polysomnography
Sleep stages will be determined using polysomnography (PSG). The proportions of N1, N2, and N3 sleep will be calculated as the percentage of total sleep time (TST) spent in each respective NREM sleep stage. Values will be reported as percentages (%). Higher values indicate a greater proportion of total sleep time spent in the corresponding sleep stage.
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Sleep Onset Latency (SOL), measured in minutes by polysomnography
Sleep onset latency (SOL) is defined as the time from the beginning of the sleep opportunity to the onset of sleep, as determined by polysomnography (PSG). SOL will be reported in minutes. A higher value indicates a longer time required to initiate sleep.
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Total Sleep Time (TST), measured in minutes by polysomnography
Total sleep time (TST) is defined as the total amount of time spent asleep during the monitoring period, as determined by polysomnography (PSG). TST will be reported in minutes. A higher value indicates a longer duration of sleep.
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Sleep Efficiency (SE), measured as a percentage by polysomnography
Sleep efficiency (SE) is defined as the percentage of time spent asleep relative to the total time in bed during the monitoring period. SE will be calculated as total sleep time (TST) divided by total time in bed, multiplied by 100. Sleep efficiency will be derived from polysomnography (PSG) data and reported as a percentage (%). Higher values indicate greater sleep efficiency.
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Serum Testosterone Concentration
Serum testosterone concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (ng/dL).
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Serum Progesterone Concentration
Serum progesterone concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (ng/mL).
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Serum Cortisol Concentration
Serum cortisol concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (μg/dL).
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Serum Estradiol (E2) Concentration
Serum estradiol concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (pg/mL).
Measured: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Secondary outcomes (2)
Sleep satisfaction (rated on a scale of 1-10, with 1 indicating very dissatisfied and 10 indicating very satisfied)
Measured: 30 minutes after waking each morning
number of nighttime awakenings (subjectively perceived)
Measured: Every morning within 30 minutes after awakening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start20 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep and Circadian ProblemsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Juan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Li Juan, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863804
- Sponsor's protocol ID
- BoYi Medical Ethics No.1632026
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All personal information of participants enrolled in this study will be kept confidential. Information that could identify individual participants will not be disclosed to anyone outside the research team unless permission has been obtained from the participant. All members of the research team and the study sponsor are required to maintain the confidentiality of participants' identities. Participants' records will be stored in locked filing cabinets and will be accessible only to authorized research personnel. To ensure that the study is conducted in accordance with applicable regulations, authorized representatives of relevant government regulatory authorities or members of the ethics committee may, when necessary, review participants' personal information at the study site in accordance with applicable requirements. No personally identifiable information of participants will be disclosed when the results of this study are published. In this clinical study, real-time data tracking wi
Publications
Paul KN, Turek FW, Kryger MH. Influence of sex on sleep regulatory mechanisms. J Womens Health (Larchmt). 2008 Sep;17(7):1201-8. doi: 10.1089/jwh.2008.0841.
PubMed 18710368Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186.
PubMed 12531146
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Perioperative Sleep Recovery Trajectories in Patients of Different Sexes Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07863804
- Acronym / sponsor ID
- BoYi Medical Ethics No.1632026
- Conditions
- Sleep and Circadian Problems
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Li JuanOther government
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Oct 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.
This is an observational clinical study. It does not give new treatments to participants. Researchers want to learn how sleep gets better or worse after laparoscopic gallbladder removal surgery. Sleep problems are common after surgery. Some people may recover their sleep faster than others. Researchers will look at whether sleep recovery differs between women and men. They will also check how sex-related hormone levels connect with sleep changes.
About 58 participants will join this study.
Key requirements to take part:
- Aged 18 to 65 years old
- Scheduled for laparoscopic gallbladder removal under general anesthesia
- Able to give informed consent and finish all study tasks
- Can tolerate repeated blood draws
- No long-term sleep-affecting medicine use in the past one month
- Major organs work normally
People cannot join if they:
- Are younger than 18 years or older than 65 years
- Are pregnant or breastfeeding
- Have mental health or cognitive conditions that stop study participation
- Have problems that make repeated blood collection unsafe
- Have severe organ diseases or recent major injury or surgery
- Have alcohol or drug dependence
What happens for each participant:
- Before surgery: Participants sign consent forms. Staff collect basic health information. Participants wear a sleep-recording device called polysomnography (PSG) overnight. Participants fill out a short sleep diary each morning. Fasting blood samples are collected the next morning to measure hormone levels.
- On surgery day: Standard hospital care goes forward. Staff record surgery-related information. PSG sleep recording, sleep diary, and morning blood draw are repeated.
- First and second days after surgery: The same sleep recording, sleep diary, and morning fasting blood collection continue for two more nights.
Researchers compare sleep measurements across four nights. These measurements come from both PSG machine readings and participants' self-reported sleep diaries. Researchers also compare hormone level changes between female and male participants.
Possible benefits: Participants receive objective feedback on their own sleep and hormone results. If test values show clear concerns, researchers share these findings with their clinical care team. No direct treatment benefit is guaranteed.
Possible risks: This is a low-risk study. Small risks may include mild pain, bruising at blood draw sites, or temporary light-headedness from blood collection. Filling out short diaries may bring minor tiredness. All personal data will be kept private. Participants can leave the study at any time with no penalty.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| man group | – | Other: No study interventionNo study intervention |
| woman group | – | Other: No study interventionNo study intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a prospective observational study designed to compare the recovery trajectories of perioperative stress-related sleep disturbances between male and female patients undergoing laparoscopic cholecystectomy. All enrolled participants will be naturally assigned to either the female group or the male group according to sex, without any study-related intervention.
Key inclusion criteria (6 listed)
- Aged 18-65 years of both genders. Alert and capable of normal communication. Voluntarily sign informed consent, complete the whole experimental procedure, and meet ethical and compliance requirements.
- Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia.
- No history of severe needle or blood phobia, and able to tolerate repeated venous blood sampling during the perioperative period.
- No long-term use of sedative-hypnotics, anxiolytics, antidepressants, or glucocorticoids within the past month, except for short-term use for acute illness for no more than 3 days; no other interventions that may affect sleep, such as transcranial magnetic stimulation or cognitive behavioral therapy.
- Stable vital signs, essentially normal function of major organs, including the heart, brain, lungs, liver, and kidneys, and no severe organic disease; able to tolerate surgery and the study procedures.
Key exclusion criteria (7 listed)
- 1: Aged <18 years or >65 years; pregnant or breastfeeding women; patients with psychiatric disorders, such as schizophrenia, mania, or depression, cognitive impairment, or inability to cooperate with the study, in order to avoid missing data or study bias due to poor cooperation.
- 2: Severe coagulation disorders, skin infection at the puncture site, or other conditions unsuitable for repeated blood sampling, to ensure the safety of blood collection procedures.
- 3: Use of sedative-hypnotics, anxiolytics, antidepressants, hormonal medications, or other sleep-related interventions within the past month that may affect the study outcomes, in order to minimize confounding factors and ensure the accuracy of the results.
- 4: Severe cardiovascular or cerebrovascular disease, severe hepatic or renal insufficiency, severe respiratory disease, or other conditions that may affect perioperative recovery or sleep assessment.
- 5: Major surgery or severe trauma within the past 3 months that may interfere with the perioperative stress response.
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 |
|---|---|---|
| No study interventionThis is a retrospective observational study based on existing medical records. No intervention, treatment, or procedure is assigned or administered by the study investigators. All data are collected retrospectively from routine clinical care. | Other | man group, woman group |
Primary outcome
Wake After Sleep Onset (WASO), measured in minutes by polysomnography
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Wake after sleep onset (WASO) is defined as the total amount of time spent awake after initial sleep onset and before final awakening during the monitoring period. WASO will be measured in minutes using polysomnography (PSG). A higher WASO indicates a greater amount of wakefulness during the sleep period.
Proportions of Rapid Eye Movement (REM) Sleep, Non-Rapid Eye Movement (NREM) Sleep, and Wakefulness measured by polysomnography
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Sleep and wake states will be determined using polysomnography (PSG). The proportions of rapid eye movement (REM) sleep, non-rapid eye movement (NREM) sleep, and wakefulness will be calculated as the percentage of the total recording time spent in each state. Values will be reported as percentages (%), with higher values indicating a greater proportion of the recording period spent in the corresponding state.
Proportions of N1, N2, and N3 stages of non-rapid eye movement (NREM) sleep measured by polysomnography
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Sleep stages will be determined using polysomnography (PSG). The proportions of N1, N2, and N3 sleep will be calculated as the percentage of total sleep time (TST) spent in each respective NREM sleep stage. Values will be reported as percentages (%). Higher values indicate a greater proportion of total sleep time spent in the corresponding sleep stage.
Sleep Onset Latency (SOL), measured in minutes by polysomnography
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Sleep onset latency (SOL) is defined as the time from the beginning of the sleep opportunity to the onset of sleep, as determined by polysomnography (PSG). SOL will be reported in minutes. A higher value indicates a longer time required to initiate sleep.
Total Sleep Time (TST), measured in minutes by polysomnography
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Total sleep time (TST) is defined as the total amount of time spent asleep during the monitoring period, as determined by polysomnography (PSG). TST will be reported in minutes. A higher value indicates a longer duration of sleep.
Sleep Efficiency (SE), measured as a percentage by polysomnography
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Sleep efficiency (SE) is defined as the percentage of time spent asleep relative to the total time in bed during the monitoring period. SE will be calculated as total sleep time (TST) divided by total time in bed, multiplied by 100. Sleep efficiency will be derived from polysomnography (PSG) data and reported as a percentage (%). Higher values indicate greater sleep efficiency.
Serum Testosterone Concentration
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Serum testosterone concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (ng/dL).
Serum Progesterone Concentration
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Serum progesterone concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (ng/mL).
Serum Cortisol Concentration
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Serum cortisol concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (μg/dL).
Serum Estradiol (E2) Concentration
Time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2
Serum estradiol concentration will be measured using an automated chemiluminescence immunoassay. The result will be reported as concentration values (pg/mL).
2 secondary outcomes
Sleep satisfaction (rated on a scale of 1-10, with 1 indicating very dissatisfied and 10 indicating very satisfied)
Time frame: 30 minutes after waking each morning
number of nighttime awakenings (subjectively perceived)
Time frame: Every morning within 30 minutes after awakening
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 7 Oct 2026.
- Background: PubMed 18710368Paul KN, Turek FW, Kryger MH. Influence of sex on sleep regulatory mechanisms. J Womens Health (Larchmt). 2008 Sep;17(7):1201-8. doi: 10.1089/jwh.2008.0841.
- Background: PubMed 12531146Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186.
- Individual participant dataSharing planned: Yes. All personal information of participants enrolled in this study will be kept confidential. Information that could identify individual participants will not be disclosed to anyone outside the research team unless permission has been obtained from the participant. All members of the research team and the study sponsor are required to maintain the confidentiality of participants' identities. Participants' records will be stored in locked filing cabinets and will be accessible only to authorized research personnel. To ensure that the study is conducted in accordance with applicable regulations, authorized representatives of relevant government regulatory authorities or members of the ethics committee may, when necessary, review participants' personal information at the study site in accordance with applicable requirements. No personally identifiable information of participants will be disclosed when the results of this study are published. In this clinical study, real-time data tracking wi
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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?
An observational study of Sleep and Circadian Problems, run by Li Juan.
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 6 inclusion and 7 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 7 Oct 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. 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 tong fu, Master (+8613156561090, futong5533227@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wake After Sleep Onset (WASO), measured in minutes by polysomnography (time frame: Day -1 (the day before surgery), Day 0 (the day of surgery), Postoperative Day 1, and Postoperative Day 2). The study lists 10 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 NCT07863804, which also lists 2 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 7 Oct 2026.