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:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT03762694
Eligibility Criteria:
Inclusion Criteria:
1. Female patients between 18 and 75 years of age;
2. Diagnosis of stage (American Joint Committee on Cancer (AJCC) TNM) I-IV breast cancer;
3. Currently receiving chemotherapy, or have completed chemotherapy no more than 6 months;
4. Insomnia onset after the diagnosis of breast cancer;
5. Insomnia occurs at least 3 nights per week, and presents for at least 1 month, with fulfilment of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for brief insomnia disorder;
6. Insomnia severity as defined by an ISI score of no less than 10 in the past 2 weeks;
7. Expected survival time of more than 6 months;
8. Ability to understand the nature of the study and willingness to give informed consent;
9. Ability to provide responses during outcome measurement.
Exclusion Criteria:
1. Insomnia before the diagnosis of breast cancer;
2. Other sleep disorder (e.g., obstructive sleep apnoea);
3. Shift work or irregular sleep pattern;
4. Severe visual, hearing or language defects;
5. Severe hematological dysfunction (platelet count \<60,000/μL, haemoglobin \<8 g/dL or absolute neutrophil count \<1000/μL);
6. With pacemakers or other electronic implants that could interfere with electroacupuncture;
7. History of acupuncture use in the previous 3 months;
8. Participation in other clinical trials with intervention within 3 months of the beginning of the trial.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03762694
Study Brief:
Protocol Section:
NCT03762694