Table 3.
Study schedule of the trial.
| Study period | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Enrollment | Allocation | Post-allocation | Follow-up period | ||||||
| Timepoint (days) | -7 | 0 | 1 | 10 | 20 | 30 | 60 | 90 | 120 |
| Enrollment | |||||||||
| Eligibility screen | X | ||||||||
| Informed consent | X | ||||||||
| Allocation | X | ||||||||
| Interventions | |||||||||
| Auricular plaster |
|
||||||||
| Sham auricular plaster |
|
||||||||
| Assessments | |||||||||
| CSHQ | X | X | X | X | X | X | X | ||
| ABC | X | X | X | X | X | X | X | ||
| PSG | X | X | |||||||
| AEs | X | X | X | ||||||
CSHQ, Children's Sleep Habits Questionnaire; ABC, Autism Behavior Checklist; PSG, polysomnography; AES, adverse events.