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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03607994
Eligibility Criteria:
Inclusion Criteria:
* Clinical Insomnia (Insomnia Severity Index ≥ 8) persisting by self-report for at least a month
* Subjects must have the ability to comply with basic instructions and be able to comfortably sit still with the sensor leads attached
Exclusion Criteria:
* Unable, unwilling, or incompetent to provide informed consent
* Physically unable to come to the study visits, or to sit in a chair for several hours
* Known seizure disorder
* Known obstructive sleep apnea
* Diagnosed periodic limb movement disorder or known restless legs syndrome
* Known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of the sleep disturbance
* Severe hearing impairment (because the subject will be using ear buds during HIRREM-SOP)
* Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications (SSRI, or SNRI's), sleep medications such as zolpidem or eszopiclone, stimulants such as Adderall, Provigil, or Ritalin, or thyroid hormone
* Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
* Weight is over the chair limit (285 pounds)
* Currently in another active intervention research study
* Previous history of receiving or using HIRREM, BWO, HIRREM-SOP, or the wearable B2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03607994
Study Brief:
Protocol Section:
NCT03607994