NCT06790979 Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Traumatic Brain Injury
| NCT ID | NCT06790979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | General Hospital of Ningxia Medical University |
| Condition | Traumatic Brain Injury (TBI); Concussion, Initial Encounter |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 50 participants in total. It began in 2024-10-01 with a primary completion date of 2025-10-30.
⚠ 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
In patients with traumatic brain injury, post-traumatic sleep patterns have the potential to impact clinical prognosis. While some progress has been made in the study of sleep and prognosis in patients with traumatic brain injury, there is still lack of research on the relationship between sleep and clinical prognosis in post-traumatic patients due to differences in study design, patient age, severity of trauma, and definitions of sleep disorders. Additionally, the primary data collection methods employed in most studies have been self-reported sleep assessments, which are subject to potential biases and inaccuracies. Therefore, explore the impact of sleep patterns on clinical prognosis in post-traumatic patients, with potential to advance our comprehension of recovery outcomes in this patient group.
Eligibility Criteria
Inclusion Criteria: 1. 18\~60 years old. 2. The patient had no sleep disturbance problems prior to traumatic brain injury. 3. The patient has a definite diagnosis of traumatic brain injury and the Glasgow score is \>8. 4. The patient had abnormal imaging scans. 5. It has complete preclinical data. Exclusion Criteria: 1. Patients with a previous history of traumatic brain injury, mental illness, alcohol abuse or sleep disorders. 2. Patients admitted for surgical intervention. 3. Patients with a combination of other heavy visceral injuries. 4. Women during pregnancy and lactation. 5. The patents' use of medications that interfere with sleep
Contact & Investigator
Zhanfeng Niu, Doctor
STUDY DIRECTOR
General Hospital of Ningxia Medical University
Frequently Asked Questions
Who can join the NCT06790979 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Traumatic Brain Injury (TBI); Concussion, Initial Encounter. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06790979 currently recruiting?
Yes, NCT06790979 is actively recruiting participants. Contact the research team at niuzfeng228626@163.com for enrollment information.
Where is the NCT06790979 trial being conducted?
This trial is being conducted at Yinchuan, China.
Who is sponsoring the NCT06790979 clinical trial?
NCT06790979 is sponsored by General Hospital of Ningxia Medical University. The principal investigator is Zhanfeng Niu, Doctor at General Hospital of Ningxia Medical University. The trial plans to enroll 50 participants.