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

NCT06790979 | Recruiting

• 1 other identifier: Jingchao Zhou
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury (TBI); Concussion, Initial Encounter

Keywords

Traumatic brain injury; Sleep; Prognosis of trauma; Wearable devices

Outcome Measures

Primary Outcomes (2)

• Change of cognitive function

  The use of MOCA to measure cognitive function in patients with TBI.

  1st day and 30th day

• Change of executive function

  The use of the TMT-B to measure executive function in patients with TBI.

  1st day and 30th day

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Qualified inpatients hospitalized in our hospital

You may qualify if:

• \~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.

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

The General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Zhanfeng Niu, Doctor

  General Hospital of Ningxia Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhanfeng Niu, Doctor

CONTACT

+8613995297581; niuzfeng228626@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: October 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: January 24, 2025

Record last verified: 2024-11

Locations

CN (1)