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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT02945306
Eligibility Criteria:
Inclusion Criteria:
1. Aged more than 2 years 6 months and less than 5 years of age at time of recruitment
2. A diagnosis of SDB based on clinical criteria.
3. Enlarged tonsils on examination (2 or more on standard Brodsky scale)
Exclusion Criteria:
1. Recurrent tonsillitis as main symptoms leading to consideration for AT
2. Known genetic, cranio-facial or psychiatric condition likely to affect airway, cognition or behaviour
3. Obesity (Body Mass Index \> 2.5 standard deviation from mean for age and gender)
4. Severe OSA (Apnoea Hypopnoea Index greater than 30 / hour on sleep study)
5. Severe chronic health conditions that may hamper participation. This may include severe congenital heart disease, cystic fibrosis, sickle cell anaemia, or poorly controlled epilepsy)
6. A history of significant hypertension (defined as greater than the 99th percentile (CDC prediction equations) plus 5mmHg for either systolic or diastolic.
7. Concurrent use of ADHD medicines, psychotropic medications (anti-depressants, anxiolytics, anti-psychotics), hypnotics or anti convulsants.
8. Previous adenotonsillectomy, tonsillectomy or adenoidectomy.
9. Receiving Continuous Positive Airway Pressure as a treatment
10. A parent or Guardian who is unable to read and thus understand the consent form.
11. A family planning to move out of the area within the next 9 months.
12. Severe snoring since birth.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Months
Maximum Age:
5 Years
Study:
NCT02945306
Study Brief:
Protocol Section:
NCT02945306