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

January 18, 2025 updated by: General Hospital of Ningxia Medical University

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • The General Hospital of Ningxia Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Qualified inpatients hospitalized in our hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of cognitive function
Time Frame: 1st day and 30th day
The use of MOCA to measure cognitive function in patients with TBI.
1st day and 30th day
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.
1st day and 30th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Ningxia Medical University

Investigators

  • Study Director: Zhanfeng Niu, Doctor, General Hospital of Ningxia Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 18, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jingchao Zhou

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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