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NCT Number: NCT06790979

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

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.

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Key information

Conditions

Traumatic Brain Injury (TBI); Concussion, Initial Encounter Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location status: Recruiting

Location contact

Zhanfeng Niu, Doctor

CONTACT

[email protected]

+8613995297581

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change of cognitive function

    Time frame: 1st day and 30th day

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

  2. Change of executive function

    Time frame: 1st day and 30th day

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

Study contacts

Contact information is provided by the study sponsor or research team.

Zhanfeng Niu, Doctor

CONTACT

[email protected]

+8613995297581

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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