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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT02543203
Eligibility Criteria:
Inclusion Criteria:
* Outpatients between 3 and 9 years of age, inclusive;
* Diagnosis of Autism Spectrum Disorder (ASD) by DSM-V;
* Mean item score of \> or = 1.5 PedsQL Inventory;
* Care provider who can reliably bring subject to clinic visits and provide trustworthy ratings.
Exclusion Criteria:
* Bipolar disorder by Child \& Adolescent Symptom Inventory (CASI, Gadow \& Sprafkin, 1997) and clinical interview/history, or major depression accompanied by family history of bipolar disorder;
* Children with allergies to essential oils;
* Children with seizure disorder/epilepsy;
* Significant physical illness (e.g., serious cardiovascular, liver or renal pathology);
* Medications specifically given for insomnia and exogenous melatonin, which have the potential to confound study results, within the previous 2 weeks before baseline;
* Anticipated changes of doses of medication or other medical treatments or supplements;
* Weight less than 10 kg;
* Sleep Disordered Breathing (SDB) as defined by a total score of \> or = 3 on the CSHQ SDB subscale and parent report;
* Nut allergies;
* Allergy to vanilla;
* A substantial trial of essential oil use within the past 6 months (i.e., consistent use for 6 weeks).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
9 Years
Study:
NCT02543203
Study Brief:
Protocol Section:
NCT02543203