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 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT06972303
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older;
* Chronic insomnia (≥ 3 nights/week, for ≥ 3 months), defined by DSM-V or ICSD-3;
* Have a primary complaint of difficulty falling asleep (sleep-onset insomnia) with self-reported sleep onset latency \>20 min;
* Insomnia Severity Index score ≥ 15;
* Speak and understand English;
* Have a smart device (phone or tablet) for mobile app installation
Exclusion Criteria:
* Current diagnosis of sleep disorders other than insomnia (e.g., narcolepsy, restless leg syndrome, REM sleep behavior disorder, etc.);
* Shift worker or routine night shifts;
* Women with pregnancy or breastfeeding;
* Regular (defined as twice a week or more) practice of mind-body interventions;
* Patients with pace-maker or routinely using cardiovascular medications that have effects on heart rates (i.e., beta-blockers);
* Neurological disorders (e.g. epilepsy, dementia, stroke, Parkinson's disease, neuroinfections, brain tumors, etc.) or current diagnosis of comorbid psychotic, substance use, and trauma-related disorders;
* Currently under medications with sleep changing effects (e.g., anxiolytics/benzodiazepines, selective serotonin reuptake inhibitors, hypnotics, etc.);
* Hearing impairment or loss. Participants will be asked to report any medication for at least 2 weeks prior to study onset and during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06972303
Study Brief:
Protocol Section:
NCT06972303