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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT01162018
Eligibility Criteria:
Inclusion Criteria:
* Females diagnosed with breast cancer who are not currently undergoing cancer treatment (hormonal treatment is permitted).
* The last cancer treatment ≥ 2 weeks prior to screening.
* ≥ 21 years of age.
* Able to understand written and spoken English.
* Have a habitual bedtime between 9:00 pm and 3:00 am and a habitual rise time between 4:00 am and 11 am.
* Meet DSM-IV criteria for insomnia (determined by the of the Duke Structured Interview of Sleep Disorders) with duration ≥ 1 month by Screening.
* Willingness to discontinue the use of any current sleep aides (prescription, OTC, or naturopathic agents).
* Properly executed Informed Consent.
* Karnofsky Performance Scale Index score ≥ to 70, (patients who score between 61-69 might be included per PI's evaluation).
* Insomnia Severity Index (ISI) \> 8 at Screening.
* Able to travel to Stanford University and vicinity for assessments and acupuncture treatments.
Exclusion Criteria:
* Unstable medical or psychiatric illness (eMINI, current or within the last 5 years).
* Exposure to acupuncture within 6 months prior to screening.
* Currently pregnant or nursing.
* History of substance abuse or meet criteria for current alcohol abuse or dependence.
* Center for Epidemiological Studies Depression Scale (CES-D) \>27 at Screening. Meet criteria for sleep apnea, restless legs syndrome or Circadian Rhythm Sleep Disorder on the basis of the Duke Structured Interview of Sleep Disorders (DSISD) or STOP-BANG is ≥ to 3.
* Major surgery within 4 weeks prior to first acupuncture treatment.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01162018
Study Brief:
Protocol Section:
NCT01162018