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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT05390918
Eligibility Criteria:
Inclusion:
* Nationwide Children's Hospital patients
* Between the ages of 11 years, 0 months, and 18 years, 11 months, inclusive at time of consent
* Endorse both recent (past 90 days) suicidal ideation and sleep problems (past 30 days)
* Resides with primary caregiver who has legal authority to consent to research participation
Exclusion:
* Suicide attempt in the past 3 months
* Diagnosis of Bipolar Disorder or Psychosis
* Having a change to an antipsychotic and/or mood stabilizer medication regimen within the last 2 months
* Snoring at least 3 nights per week that can be heard a room or two away, even without a cold or flu or during allergy season
* Gasping for air while sleeping, diagnosis of Obstructive Sleep Apnea, or turning blue within the past year
* Body Mass Index \> 40
* Daytime symptoms of Restless Leg Syndrome
* Diagnosis of Narcolepsy
* Diagnosis of Seizures or Epilepsy, or prescribed anticonvulsant medication, within the past 4 years
* Significant substance use in the past month
* Currently receiving sleep disorder services from a sleep clinic
* Inability to speak/read English adequately to understand and complete study consent and procedures
* No access to a telephone or internet-connecting device
* Sibling already in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
18 Years
Study:
NCT05390918
Study Brief:
Protocol Section:
NCT05390918