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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT03727906
Eligibility Criteria:
Inclusion Criteria:
* Must be post-pubertal
* BMI \<30 kg/m-2 to reduce the likelihood of obesity-related sleep-disordered breathing
Exclusion Criteria:
* Current use of drugs known to affect sleep and CV systems (e.g., Antidepressants, stimulants, beta-blockers)
* Serious history of, or current medical conditions that could affect brain function, or study participation, including Diabetes, cancer, neurological diseases (e.g., Seizure disorders) recurrent migraine, cardiovascular diseases (e.g., Hypertension) and traumatic brain injury with loss of consciousness \>30 minutes
* Current DSM-5 diagnosis of Neurodevelopmental Disorders (e.g., Attention-Deficit/Hyperactivity Disorder)
* Current DSM-5 diagnosis of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders
* Current DSM-5 diagnosis of Depressive and Anxiety Disorders (e.g., Major Depressive Disorder)
* Current DSM-5 diagnosis of Post-Traumatic Stress Disorder
* Current DSM-5 diagnosis of Substance-Related and Addictive Disorders (e.g., Alcohol Use Disorder)
* History of and persistence in severe learning disorder, pervasive developmental disorder, or other condition requiring repeated or persistent specialized education (e.g., Estimated intellectual quotient (IQ) \>2 standard deviations below mean)
* Current psychiatric disorders in both control and insomnia groups is exclusionary
* Past history of psychiatric disorders in controls is exclusionary (past history of psychiatric disorders in the insomnia group is not exclusionary)
* Shift work in the previous year and no time-zone travel in the past month
* Evidence of other DSM-5 Sleep-Wake Disorders (e.g., Narcolepsy), Breathing-Related Sleep Disorders (e.g., Obstructive Sleep Apnea Hypopnea, Circadian Rhythm Sleep-Wake Disorders and particularly Delayed Sleep Phase Type), and Parasomnias (e.g., Non-Rapid Eye Movement Sleep Arousal Disorders, Rapid Eye Movement Sleep Behavior Disorder and Restless Legs Syndrome)
* Current pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
20 Years
Study:
NCT03727906
Study Brief:
Protocol Section:
NCT03727906