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

Recruiting

• Conditions: Traumatic Brain Injury (TBI); Concussion, Initial Encounter

• Registration Number: NCT06790979
• Lead Sponsor: General Hospital of Ningxia Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2024-11
• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-18
• Last Update Submitted: 2025-01-18
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

The General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China