Evaluating home sleep tests for children with sleep apnea after surgery
Home Sleep Apnea Testing for the Evaluation of Obstructive Sleep Apnea in Children Following Management With Adenotonsillectomy
This study is testing if home sleep tests can accurately check for sleep apnea in children aged 5 to 12 after they've had surgery to remove their tonsils and adenoids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 12 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05516524 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the diagnostic accuracy of home sleep apnea testing (HSAT) with traditional polysomnography (PSG) in assessing obstructive sleep apnea (OSA) in children who have undergone adenotonsillectomy. Given the resource-intensive nature of PSG and its limited availability, HSAT may provide a more convenient and accessible alternative for evaluating treatment outcomes in pediatric patients. The study will involve children aged 5 to 12 years who have a history of OSA and adenotonsillectomy, allowing researchers to determine the effectiveness of HSAT in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to 12 years who have undergone adenotonsillectomy for obstructive sleep apnea.
Not a fit: Patients with a history of hypoventilation, hypoxemia, or those requiring supplemental oxygen during sleep may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and efficient method for diagnosing residual sleep apnea in children after surgery.
How similar studies have performed: Other studies have shown promising results using home sleep apnea testing in adults, but this approach in children is relatively novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female children age 5-12 years old inclusive * History of adenotonsillectomy for OSA Exclusion Criteria: * Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep * Children with a tracheostomy or tracheocutaneous fistula * Children who live in a facility without their parent
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Christopher M Cielo, DO — Children's Hospital of Philadelphia
- Study coordinator: Yaelis Roman-Rosado, BS
- Email: romanyd@chop.edu
- Phone: 215-590-9184
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.