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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06790979

Enrollment

Registered

2025-01-24

Start date

2024-10-01

Completion date

2025-10-30

Last updated

2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury (TBI); Concussion, Initial Encounter

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactZhanfeng Niu, Doctor

niuzfeng228626@163.com+8613995297581

Outcome results