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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT01790256
Eligibility Criteria:
Inclusion Criteria:
Age \>/= 22
Diagnosis of insomnia that meets criteria for DSM IV diagnosis of primary insomnia and International Classification of Sleep Disorders (ICSD)general insomnia criteria and RDC insomnia disorder criteria
Subjects must remain alcohol-free and avoid drugs that could affect sleep during the study.
\>14 on the Insomnia Severity Index
Sleep -Wake diaries demonstrate sleep efficiency \<85% on at least 50% of nights
Exclusion Criteria:
Neuropsychiatric disorders that may independently affect sleep, brain function or cognition, such as current major syndromal psychiatric disorders, including DSM-IV mood, anxiety, psychotic, and substance use disorders.
Specific exclusionary diagnoses include major depressive disorder, dysthymic disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, generalized anxiety disorder, any psychotic disorder, and any current substance use disorder.
Unstable medical conditions Raynaud's Disease
Irregular sleep schedules including shift workers;
A latency to persistent sleep \< 15 on either the sleep disorder screening night or the baseline PSG sleep night;
A sleep efficiency \> 85% on either the sleep disorder screening night or the baseline PSG sleep night;
An AHI (apnea hypopnea index) \> 10 and/or a periodic limb movement arousal index (PLMAI) \> 15 from SN1
Body Mass Index \>34
Use of medications known to affect sleep or wake function
Consumption of more than one alcoholic drink per day, or more than 7 drinks per week prior to study entry.
Caffeinated beverages \> 4/day or the equivalent of more than 4 cups of coffee Unable to read or understand English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT01790256
Study Brief:
Protocol Section:
NCT01790256