Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT06990256
Eligibility Criteria:
Inclusion Criteria:
* Aged 45-70 years;
* Total score \> 5 points on the Pittsburgh Sleep Quality Index (PSQI) for sleep quality assessment;
* Able to use personal mobile devices for WeChat, internet access, and related operations;
* Informed about the intervention trial and willing to undergo sleep monitoring and other examinations during the study;
* Commitment to consume coffee, strong tea, or alcohol ≤1 time per week during the trial period;
Exclusion Criteria:
* Participation in any clinical trials or dietary/exercise intervention programs within the past 3 months or concurrently;
* Diagnosis of major mental disorders or family history thereof, or current use of psychotropic drugs or mood-regulating medications;
* Experiencing major psychological trauma (e.g., death of a close relative, significant financial loss) personally or within the family in the past 3 months;
* Severe diseases affecting inflammatory levels and/or endocrine components (e.g., severe obesity, uncontrolled diabetes or poorly controlled blood glucose, myocardial infarction, cerebral infarction);
* Current use of hormonal medications, beta-blockers, steroids, non-steroidal anti-inflammatory drugs (NSAIDs), etc.;
* Use of medications potentially affecting sleep or aging biomarkers (e.g., melatonin, antidepressants, anxiolytics) within the past 3 months;
* Plans for relocation or long-term travel within the next 6 months, which may hinder continuous intervention and follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT06990256
Study Brief:
Protocol Section:
NCT06990256