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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT02812368
Eligibility Criteria:
Inclusion Criteria:
* outpatients between 6-14 years of age, inclusive, from underserved populations (i.e., Low SES, racial and ethnic minorities, rural populations);
* diagnosis of Autism Spectrum Disorder based on DSM-V criteria and the ATN assessment protocol;
* mental age ≥ 24 months as determined by the Stanford Binet-Fifth Edition (SB-5) or Mullen Scales of Early Learning (MSEL) (the child must be of a mental age to understand the BI/SH protocol);
* significant sleep disturbance as determined the CSHQ 33-item Total Score of ≥ 48 and one of the following for the past four weeks by parent interview;
1. ≥ 30 minutes delayed sleep onset, ≥ 3 times per week
2. Sleep association problems, ≥ 3 nights per week, child falls asleep in a location other than his/her bed and requires parental intervention to return to his/her bed
3. Nighttime Awakenings, ≥ 3 times per week, and child disturbs parent or enters into the parents' bedroom.
4. Early Morning Awakenings, before 5 am ≥ 3 times per week and the child disturbs family members
* CGI Severity rating of ≥ 4 (Moderate) by the independent evaluator for sleep onset and/or sleep maintenance disruption at BL 2;
* care provider who can reliably bring subject to clinic visits and provide trustworthy ratings;
* stable dose of psychotropic medications (for at least 4 weeks with no plans to change over the course of the study);
* anticonvulsant if used for mood lability and it is working well;
* stable dose of exogenous melatonin for at least 4 weeks with no plans to change over the course of the study, as long as Phase II eligibility criteria are met prior to enrollment;
* sleep hygiene education responders who have relapsed and meet the Phase II study eligibility criteria
Exclusion Criteria:
* DSM-V diagnosis of bipolar disorder;
* subjects who are either melatonin naïve or who have not had an adequate trial of exogenous melatonin (defined as 3-5 mg for ≥ 4 weeks);
* seizure disorder/epilepsy;
* significant physical illness (e.g., serious cardiovascular, liver or renal pathology);
* medications specifically given for insomnia;
* pregnancy or sexually-active females without birth control;
* taking supplements or other complementary medical treatments where dose cannot be held at current level for duration of study;
* weight less than 15 kg;
* use of medicines for physical ailments that might interact with CLN or TRZ, such as guanfacine (Tenex, Intuniv), and propranolol (Inderol) or extended release clonidine (Kapvay);
* allergy to CLN or TRZ;
* Sleep Disordered Breathing (SDB) as defined by a total score of ≥ 3 on the CSHQ SDB subscale and parent report;
* prior adequate trial of CLN for sleep disturbance defined as at least 0.2mg q hs for 1 week;
* prior adequate trial of TRZ for sleep disturbance defined as ≥ 50 mg/day for 1 week;
* hyperthyroidism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
14 Years
Study:
NCT02812368
Study Brief:
Protocol Section:
NCT02812368