NCT06157008 Brain Network Analysis of Anesthesia Characteristics in Patients With pDoC Based on PSG
| NCT ID | NCT06157008 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Disorders of Consciousness |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-11 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2023-01-11 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this prospective, exploratory and observational study is to learn about in healthy volunteers and patients with prolonged disorders of consciousness(pDoC). The main questions it aims to answer are: 1. Observe the similarities and differences of polysomnography between pDoC patients and healthy volunteers, and analyze the characteristic brain network changes based on polysomnography 2. To observe the similarities and differences of polysomnography in pDoC patients before and after Insertion of spinal cord electric stimulator under general anesthesia,and analyze the changes of anesthesia characteristic brain network in patients with consciousness disorders based on polysomnography. 3. To observe the similarities and differences of polysomnography in pDoC patients before and after spinal cord stimulation,and analyze the characteristic changes of brain network after spinal cord stimulation. We will record the 8h polysomnography of healthy volunteers,record the polysomnography of DOC patients before and 24 hours after operation;and record the 24h polysomnography of patients with spinal cord electric stimulator.
Eligibility Criteria
Inclusion Criteria: * Inclusion criteria of health volunteer group: 1. Aged 18-65, native Chinese 2. No history of sleep apnea 3. No history of insomnia 4. Volunteer to participate in this study and obtain informed consent. * Inclusion criteria of pDoC group: 1. Aged 18-65, native Chinese 2. pDoC after acquired brain injury 3. The spinal electric stimulator was implanted under general anesthesia 4. Obtain informed consent. * Exclusion Criteria: 1. Healthy volunteers took hypnotic drugs 72 hours before the study 2. Continuous sedation treatment was carried out within 72 hours before the study 3. The integrity of brain structures such as open head injury and brain parenchyma resection 4. Intracranial compliance decreased due to hydrocephalus 5. Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons 6. Known or suspected to have serious heart, lung and kidney dysfunction 7. Allergic history of sedative drugs 8. Combined with other mental or nervous system diseases 9. Other reasons are not suitable for this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06157008 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Disorders of Consciousness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06157008 currently recruiting?
Yes, NCT06157008 is actively recruiting participants. Contact the research team at ruquan.han@ccmu.edu.cn for enrollment information.
Where is the NCT06157008 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06157008 clinical trial?
NCT06157008 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 60 participants.