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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01971567
Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe clinical insomnia (Insomnia Severity Index score of 15 or higher)
Exclusion Criteria:
* Unable, unwilling, or incompetent to provide informed consent
* Physically unable to come to the study visits
* Known obstructive sleep apnea
* Diagnosed periodic limb movement disorder or known restless legs syndrome
* Known seizure disorder
* Known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of the sleep disturbance
* Severe hearing impairment
* Known, or suspected diagnosis of post-traumatic stress disorder (PTSD)
* Known, relevant traumatic brain injury (TBI)
* Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications such as SSRI, SNRI, or tricyclics, and sleep medications such as zolpidem or eszopiclone
* Anticipated and ongoing use of recreational drugs or alcohol
* Lack of internet or smart phone access
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01971567
Study Brief:
Protocol Section:
NCT01971567