Students With Sleep DisordersNCT06200805
ai Chi Reduces Insomnia in College Students: Exploring Inflammatory Factor Roles
A study testing tai ji quan in people with Students With Sleep Disorders, run by Anhui Medical University at 1 site in China.
Trial summary
College student volunteers were recruited from a university in Anhui Province, China, and screened by the Pittsburgh sleep quality index (PSQI) scale, and those with PSQI scores higher than 7 were considered to have clinical insomnia, and insomniac college students screened were subjected to a 24-week 24-form… Read more about this study
- Who is it for?
- Ages 17 to 24 years
- Conditions the study is for
- Students With Sleep Disorders
- What is being tested?
- tai ji quan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2024to 20 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet the diagnostic criteria of insomnia i.e. PSQI score ≥ 7;
- Age between 18 and 25 years old; ③ Exercise of the study subjects is low exercise i.e. PARS-3 score ≤ 19;
- Have not received any psychological and pharmacological treatments in the past one year;
- Have no visceral diseases, normal vision and hearing; ⑥ Have good physical fitness and can perform basic intensity of physical exercise; ⑦ Have signed the informed consent form.
Who cannot join
- Recent cardiovascular disease, musculoskeletal disease and other diseases that affect normal sports training;
- Serious mental illness; ③ Antibiotics within the past three months; ④ Serious autoimmune disease; ⑤ Those who refuse to participate in the research project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Intervention Effect of Tai Chi on College Students With Insomnia and the Potential Role of Inflammatory Factors
College student volunteers were recruited from a university in Anhui Province, China, and screened by the Pittsburgh sleep quality index (PSQI) scale, and those with PSQI scores higher than 7 were considered to have clinical insomnia, and insomniac college students screened were subjected to a 24-week 24-form taijiquan intervention, and the rest of the insomniac volunteers were randomly divided into the fast-walking group and the control group. As the most common form of physical exercise for college students and the easiest aerobic exercise, brisk walking was chosen as an intervention for insomniac college students to better compare the efficacy of tai chi with that of general aerobic exercise for insomnia. The taijiquan group performed taijiquan exercise three times a week for 60 minutes each time, the brisk walking group performed brisk walking training three times a week for 60 minutes each time, and the control group did not carry out any intervention and maintained a normal life and study status. Before the intervention, questionnaires were filled out and fasting elbow venous blood was drawn, and the staff uniformly explained the intervention-related contents and precautions, and after 24 weeks of intervention, the post-test questionnaires and fasting venous blood were filled out centrally.
Read the detailed description
Insomnia: measured by PSQI scale. The scale was developed by Buysse et al, a neurologist at the University of Pittsburgh, USA, and has an overall internal consistency Cronbach's ɑ coefficient of 0.83.The scale was used to assess the quality of sleep of an individual in the last month, and consists of 19 self-assessed and 5 other-assessed entries, for a total of 24 items, where the 19th entry and the five other-assessed entries do not participate in the scoring. The 18 scoring items include seven dimensions: subjective sleep quality, time to sleep, sleep efficiency, sleep disorders, hypnotic drug use, and daytime functioning. Each dimension is scored on a scale of 0-3, and the cumulative score is the total PSQI score, which ranges from 0-21, with higher scores indicating poorer sleep quality, and PSQI scores greater than 7 are considered clinical insomnia.
Physical activity: was measured using the Physical activity rating scale-3 (PARS-3). The scale has a revised by Liang Deqing et al. with a retest reliability of 0.82. The scale determines the amount of exercise in terms of intensity, time, and frequency of participation in physical activities. Exercise volume = exercise intensity × time × frequency, intensity and frequency are scored on a scale of 1 to 5, assigning 1 to 5 points respectively, and time is scored on a scale of 1 to 5, assigning 0 to 4 points respectively. The score range of the scale was 0-100 points, and the score of ≤19 points was low exercise, 20-42 points was medium exercise, and ≥43 points was high exercise.
- Conditions
- Students With Sleep Disorders
- Being tested
- tai ji quan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tai ji quanBehavioural
24-Style Taijiquan as an Intervention for College Students with Insomnia
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Taijiquan Exercise Group | Experimental | 60 minutes of tai chi exercise 5 times a week Receives: Behavioral: tai ji quan |
| Moderate Intensity Taijiquan Exercise Group | Experimental | 60 minutes of tai chi exercise 3 times a week Receives: Behavioral: tai ji quan |
| control subjects | No intervention | The control group did not implement any intervention and maintained a normal life and study status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role effects of tai chi intervention in college students with insomnia
Insomnia: measured by PSQI scale. The scale was developed by Buysse et al, a neurologist at the University of Pittsburgh, USA, and has an overall internal consistency Cronbach's ɑ coefficient of 0.83.The scale was used to assess the quality of sleep of an individual in the last month, and consists of 19 self-assessed and 5 other-assessed entries, for a total of 24 items, where the 19th entry and the five other-assessed entries do not participate in the scoring. The 18 scoring items include seven dimensions: subjective sleep quality, time to sleep, sleep efficiency, sleep disorders, hypnotic drug use, and daytime functioning. Each dimension is scored on a scale of 0-3, and the cumulative score is the total PSQI score, which ranges from 0-21, with higher scores indicating poorer sleep quality, and PSQI scores greater than 7 are considered clinical insomnia.
Use of this scale to assess the improvement of insomnia in insomniac college students using taijiquan
Measured: Minimum 12 weeks
Changes in inflammatory factors before and after tai chi intervention
Fasting elbow vein blood of 2 ml was collected from college students in the tai chi group, the fast walking group, and the control group. 2 ml of blood was tested using Luminex multifactor assay technology. The levels of IL-2, IL-4, IL-6, IL-10, TNF-ɑ, IFN-Y, IL-8, IL-13, and IL-1 in the supernatant were measured.
Inflammatory factor data before and after exercise were analyzed in each group to observe the level of inflammatory factor changes before and after taijiquan intervention and to explore the role played by inflammatory factor changes in taijiquan intervention for insomniac college students.
Measured: Minimum 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 May 2024
- Primary completion20 Jun 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Students With Sleep DisordersStudies of the same condition, open and under way.
- More trials run by Anhui Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Hai Lan, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200805
- Sponsor's protocol ID
- WLan
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2023
- Last updated
- 18 Dec 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Intervention Effect of Tai Chi on College Students With Insomnia and the Potential Role of Inflammatory Factors
- ClinicalTrials.gov ID
- NCT06200805
- Acronym / sponsor ID
- WLan
- Conditions
- Students With Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 11 Jan 2024 (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.
College student volunteers were recruited from a university in Anhui Province, China, and screened by the Pittsburgh sleep quality index (PSQI) scale, and those with PSQI scores higher than 7 were considered to have clinical insomnia, and insomniac college students screened were subjected to a 24-week 24-form taijiquan intervention, and the rest of the insomniac volunteers were randomly divided into the fast-walking group and the control group. As the most common form of physical exercise for college students and the easiest aerobic exercise, brisk walking was chosen as an intervention for insomniac college students to better compare the efficacy of tai chi with that of general aerobic exercise for insomnia. The taijiquan group performed taijiquan exercise three times a week for 60 minutes each time, the brisk walking group performed brisk walking training three times a week for 60 minutes each time, and the control group did not carry out any intervention and maintained a normal life and study status. Before the intervention, questionnaires were filled out and fasting elbow venous blood was drawn, and the staff uniformly explained the intervention-related contents and precautions, and after 24 weeks of intervention, the post-test questionnaires and fasting venous blood were filled out centrally.
Detailed description
Insomnia: measured by PSQI scale. The scale was developed by Buysse et al, a neurologist at the University of Pittsburgh, USA, and has an overall internal consistency Cronbach's ɑ coefficient of 0.83.The scale was used to assess the quality of sleep of an individual in the last month, and consists of 19 self-assessed and 5 other-assessed entries, for a total of 24 items, where the 19th entry and the five other-assessed entries do not participate in the scoring. The 18 scoring items include seven dimensions: subjective sleep quality, time to sleep, sleep efficiency, sleep disorders, hypnotic drug use, and daytime functioning. Each dimension is scored on a scale of 0-3, and the cumulative score is the total PSQI score, which ranges from 0-21, with higher scores indicating poorer sleep quality, and PSQI scores greater than 7 are considered clinical insomnia.
Physical activity: was measured using the Physical activity rating scale-3 (PARS-3). The scale has a revised by Liang Deqing et al. with a retest reliability of 0.82. The scale determines the amount of exercise in terms of intensity, time, and frequency of participation in physical activities. Exercise volume = exercise intensity × time × frequency, intensity and frequency are scored on a scale of 1 to 5, assigning 1 to 5 points respectively, and time is scored on a scale of 1 to 5, assigning 0 to 4 points respectively. The score range of the scale was 0-100 points, and the score of ≤19 points was low exercise, 20-42 points was medium exercise, and ≥43 points was high exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Taijiquan Exercise Group | Experimental | Behavioral: tai ji quan60 minutes of tai chi exercise 5 times a week |
| Moderate Intensity Taijiquan Exercise Group | Experimental | Behavioral: tai ji quan60 minutes of tai chi exercise 3 times a week |
| control subjects | No intervention | –The control group did not implement any intervention and maintained a normal life and study status. |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria of insomnia i.e. PSQI score ≥ 7;
Key exclusion criteria (2 listed)
- Recent cardiovascular disease, musculoskeletal disease and other diseases that affect normal sports training;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tai ji quan24-Style Taijiquan as an Intervention for College Students with Insomnia | Behavioural | High Intensity Taijiquan Exercise Group, Moderate Intensity Taijiquan Exercise Group |
Primary outcome
Role effects of tai chi intervention in college students with insomnia
Time frame: Minimum 12 weeks
Insomnia: measured by PSQI scale. The scale was developed by Buysse et al, a neurologist at the University of Pittsburgh, USA, and has an overall internal consistency Cronbach's ɑ coefficient of 0.83.The scale was used to assess the quality of sleep of an individual in the last month, and consists of 19 self-assessed and 5 other-assessed entries, for a total of 24 items, where the 19th entry and the five other-assessed entries do not participate in the scoring. The 18 scoring items include seven dimensions: subjective sleep quality, time to sleep, sleep efficiency, sleep disorders, hypnotic drug use, and daytime functioning. Each dimension is scored on a scale of 0-3, and the cumulative score is the total PSQI score, which ranges from 0-21, with higher scores indicating poorer sleep quality, and PSQI scores greater than 7 are considered clinical insomnia. Use of this scale to assess the improvement of insomnia in insomniac college students using taijiquan
Changes in inflammatory factors before and after tai chi intervention
Time frame: Minimum 12 weeks
Fasting elbow vein blood of 2 ml was collected from college students in the tai chi group, the fast walking group, and the control group. 2 ml of blood was tested using Luminex multifactor assay technology. The levels of IL-2, IL-4, IL-6, IL-10, TNF-ɑ, IFN-Y, IL-8, IL-13, and IL-1 in the supernatant were measured. Inflammatory factor data before and after exercise were analyzed in each group to observe the level of inflammatory factor changes before and after taijiquan intervention and to explore the role played by inflammatory factor changes in taijiquan intervention for insomniac college students.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tai ji quan in people with Students With Sleep Disorders, run by Anhui 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 18 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role effects of tai chi intervention in college students with insomnia (time frame: Minimum 12 weeks). 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 18 Dec 2025.