NCT02693977

Use of Sleep Endoscopy to Predict Outcomes of Pediatric Adenotonsillectomy

Completed Last updated 22 August 2023

What this trial tests

trial testing Sleep Endoscopy in Obstructive Sleep Apnea in 347 participants. Completed in 31 March 2023.

Timeline

1 February 2015

Primary endpoint
9 November 2022

31 March 2023

Quick facts

Lead sponsor	Oregon Health and Science University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	347
Start date	1 February 2015
Primary completion	9 November 2022
Estimated completion	31 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Sleep Endoscopy

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

Oregon Health and Science University

Who can join

Adults 2 to 18, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pediatric obstructive sleep apnea (OSA) is associated with heavy snoring and brief pauses in breathing during sleep. It affects at least 1-3% of the general pediatric population with greater prevalence among certain high risk groups such as children with obesity, Down syndrome, craniofacial anomalies, or neuromuscular disorders. Several studies have shown that, even after having adenotonsillectomy (AT), approximately 30% of children continue to struggle with OSA. They further found that older children (age \> 7 yrs), obesity, and high pre-operative OSA severity were all risk factors contributing to residual OSA. Despite these known risk factors, the ability to predict each individual patient's risk of residual OSA after tonsil surgery is difficult. Determining what tool will best predict residual OSA is an important step towards more effective post-surgery OSA management.

The purpose of this study is to determine whether sleep endoscopy can predict whether their AT will be successful as a treatment for OSA. Our hypothesis is that subjects with multiple areas of obstruction in addition to large tonsils will be more likely to have residual OSA after AT. Sleep endoscopy is a procedure performed during drug-induced sleep that involves passing a flexible endoscope through the subject's nose into the back of the throat to look for sources of obstruction while breathing spontaneously.

This will be a prospective cohort study examining subjects between the ages of 2 and 18 who are having AT for treatment of obstructive sleep apnea (OSA) and are considered high risk for residual OSA after surgery. High risk will be defined based on the following criteria: obesity, Down syndrome, African American race, severe baseline OSA, and age \> 7 yrs. Eligible subjects will be recruited from the pediatric otolaryngology clinic at the time of initial evaluation for AT. Subjects will undergo a sleep endoscopy under moderate sedation at the time of AT. All patients will be asked to complete a preoperative sleep study to confirm the diagnosis of OSA and a postoperative sleep study to determine the impact of AT and the presence of residual OSA. Secondary outcome measures will include several questionnaires assessing generic and OSA-specific quality of life as well as subjective measures of cognitive/executive functioning and daytime sleepiness.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.