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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02319993
Eligibility Criteria:
Inclusion Criteria:
* Insomnia disorders in patients 20-80 years of age, the Pittsburgh Sleep Assessment Scale (PSQI)\> 6 points.
* No insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction, heart rate is not the whole), hypertension, diabetes, cancer and so on.
* There are more than a week (including) three times to be more than 30 minutes to fall asleep and sleep less than six hours, there is a continuous months.
* Test subjects had to really understand the nature of this study, and participants signed consent.
Exclusion Criteria:
* Before participating in this study, three months, had a major accident or wheel graveyard shift or jet lag problems (such as a long flight).
* Any insomnia caused by other diseases. For example: mental illness (depression, etc.), sleep apnea, heart disease (acute myocardial infarction), poorly controlled hypertension (\> 140 / 90mmHg), poorly controlled diabetes (HbA1C\> 7%), cancer, digestive ulcers (undergoing treatment).
* 2 weeks into the experiment of taking melatonin or melatonin agonist, acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins and other drugs.
* If patients sleep disorders arise from nighttime urinary frequency. Pregnant or breastfeeding person.
* Patients unable to read and fill out the questionnaire by themselves this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02319993
Study Brief:
Protocol Section:
NCT02319993