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Clinical Trials in China / NCT06790979
Recruiting Observational

Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Traumatic Brain Injury

NCT06790979 · tracked via the Priya Life Science China tracker
Sponsor
General Hospital of Ningxia Medical University
Phase
Observational
Started
2024-10-01
Last updated
2025-01-24

Condition(s) studied

Traumatic Brain Injury (TBI); Concussion, Initial Encounter

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change of cognitive function — 1st day and 30th day
    The use of MOCA to measure cognitive function in patients with TBI.
  • Change of executive function — 1st day and 30th day
    The use of the TMT-B to measure executive function in patients with TBI.

Trial sites (1)

FacilityCityRegionStatus
The General Hospital of Ningxia Medical University Yinchuan Ningxia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06790979 on ClinicalTrials.gov ↗ ← All trials in China