Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury (TBI); Concussion, Initial Encounter. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Mild to Moderate Traumatic Brain Injury
Overview
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.
Primary outcome measures
- Change of cognitive function [Time frame: 1st day and 30th day]
- Change of executive function [Time frame: 1st day and 30th day]
Eligibility criteria
Inclusion criteria
- 18\~60 years old.
- The patient had no sleep disturbance problems prior to traumatic brain injury.
- The patient has a definite diagnosis of traumatic brain injury and the Glasgow score is >8.
- The patient had abnormal imaging scans.
- It has complete preclinical data.
Exclusion criteria
- Patients with a previous history of traumatic brain injury, mental illness, alcohol abuse or sleep disorders.
- Patients admitted for surgical intervention.
- Patients with a combination of other heavy visceral injuries.
- Women during pregnancy and lactation.
- The patents' use of medications that interfere with sleep
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The General Hospital of Ningxia Medical University — Yinchuan
Identifiers
NCT: NCT06790979 · Jingchao Zhou