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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT07288593
Eligibility Criteria:
Inclusion Criteria:
* Defense Enrollment Eligibility Reporting System (DEERS) Eligible
* Current or former military service member
* Able to read and understand English language without the use of an interpreter
* Habitual bedtime between 9:00 PM and 1:00 AM
* Aged 18-62 (inclusive)
* Able to commit to study procedures
Exclusion Criteria:
* Use of alpha or beta-receptor active medications or prescribed sleep aids in the last 3 months
* Started use of SNRIs or SSRIs in the last 3 months
* Pregnant
* Receiving ongoing and extensive treatment for a new or acute psychiatric disorder within 90 days, other than routine follow-up and care
* Starting concurrent evidence based psychiatric treatment within the past three months
* Diagnosis of a serious medical condition (i.e., late-stage cancer or heart disease)
* Routine night shift work in the past 3 months
* Unstable neurological disease/autonomic disorders/ heart conditions/psych/ sleep or other unstable disorder as determined by the Principal Investigator/Associate
* Investigators determined by clinical interview by Mini international neuropsychiatric interview and medical health questionnaire
* Excessive alcohol use as determined by the AUDIT-C (AUDIT-C \> 3)
* Started using any other medication (prescribed or over-the-counter) for the purpose of improving sleep in the last 90 days (e.g., barbiturates, benzodiazepines, melatonin, natural supplements and herbs, antidepressants, antihistamines, etc.)
* Receiving treatment for substance use disorder within 90 days from the start of the study
* Evidence of moderate or severe Obstructive Sleep Apnea (OSA): Determined by the STOP-BANG questionnaire: STOP-BANG greater than 5 Determined by EMR PSG records: moderate or severe OSA \[apnea-hypopnea index (AHI)≥15\]
* Clinically significant suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Currently participating in other research studies for improving sleep
* Currently participating in other research studies for improving PTSD
* Currently in therapy for the primary purpose of improving sleep (e.g., CBT-I)
* Currently undergoing other treatment to improve sleep (e.g., acupuncture)
* History or diagnosis of any of the following sleep disorders: narcolepsy, shift-work disorder or circadian rhythm disorders
* Prone to problems with venipuncture including fainting, hematoma, and infection
* Moderate and high nicotine dependence based on the Fagerstrom Test for Nicotine Dependence (\> 4 on the Fagerstrom Test for Nicotine Dependence) High caffeine dependence based on the Caffeine Dependence Questionnaire (\> 30 on the Caffeine Dependence Questionnaire)
* Currently experiencing a neurological disorder (e.g., stroke, Parkinson's, MS, etc.)
* Exclusion for optional MRI visit:
Metal in body that is ferromagnetic / incompatible with MRI or other safety issues and indicated by screen Previous adverse reactions to sleep deprivation Illicit drug use as determined by participant self-report Alcohol in system at time of MRI overnight as determined participant self report Nicotine use in the last 3 months
For poor sleep group:
TBI History of epilepsy or suspected seizure disorder.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
62 Years
Study:
NCT07288593
Study Brief:
Protocol Section:
NCT07288593