Traumatic Brain Injury (TBI); Concussion, Initial EncounterNCT06790979
Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Traumatic Brain Injury
An observational study of Traumatic Brain Injury (TBI); Concussion, Initial Encounter, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury (TBI); Concussion, Initial Encounter
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Qualified inpatients hospitalized in our hospital
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Zhanfeng Niu, Doctor, +8613995297581, niuzfeng228626@163.com
About this study
Official title: 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.
- Keywords
- Traumatic brain injury, Sleep, Prognosis of trauma, Wearable devices
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cognitive function
The use of MOCA to measure cognitive function in patients with TBI.
Measured: 1st day and 30th day
Change of executive function
The use of the TMT-B to measure executive function in patients with TBI.
Measured: 1st day and 30th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Oct 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI); Concussion, Initial EncounterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhanfeng Niu, Doctor, Study director, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790979
- Sponsor's protocol ID
- Jingchao Zhou
- Status last verified
- Nov 2024
- First submitted
- 18 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Mild to Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06790979
- Acronym / sponsor ID
- Jingchao Zhou
- Keywords
- Traumatic brain injury, Sleep, Prognosis of trauma, Wearable devices
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Qualified inpatients hospitalized in our hospital
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of cognitive function
Time frame: 1st day and 30th day
The use of MOCA to measure cognitive function in patients with TBI.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhanfeng Niu, Doctor study director
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury (TBI); Concussion, Initial Encounter, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhanfeng Niu, Doctor (+8613995297581, niuzfeng228626@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of cognitive function (time frame: 1st day and 30th day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.