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

NCT ID: NCT06790979

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury (TBI); Concussion, Initial Encounter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhanfeng Niu, Doctor

Role: STUDY_DIRECTOR

General Hospital of Ningxia Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhanfeng Niu, Doctor

Role: CONTACT

+8613995297581

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhanfeng Niu, Doctor

Role: primary

+8613995297581

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Jingchao Zhou

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.