Use of Sleep Endoscopy to Predict Outcomes of Pediatric Adenotonsillectomy

NCT02693977 | Completed

• 2 other identifiers: IRB000098251K23HL127132-01A1
• Study Type: observational
• Target: 347
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

OSA; sleep apnea; AT; adenotonsillectomy; pediatric

Outcome Measures

Primary Outcomes (1)

• Presence of residual OSA on postoperative overnight sleep studies

  Polysomnography results

  3 months post-op

Secondary Outcomes (5)

• Sleep-issue-specific quality of life

  1 month post-op

• Subjective measure of cognitive/executive functioning

  1 month post-op

• Subjective measure of daytime sleepiness

  1 month post-op

• OSA-specific quality of life

  1 month post-op

• Generic quality of life

  1 month post-op

Interventions

Sleep Endoscopy PROCEDURE

Sleep endoscopy will be performed prior to the adenotonsillectomy, under the same general anesthetic. The endoscopy will be performed using a flexible fiber optic endoscope which will be advanced trans nasally into the pharynx down to the level of the hypopharynx. We will take note of any obvious septal deviation or nasal obstruction as well as adenoid hypertrophy, and dynamic collapse at the level of the velum, oropharynx/lateral walls, tongue base, epiglottis, and supraglottis. Relatively fixed structures such as the nasal airway and adenoids should require 1 minute to fully assess. The endoscope will then be held for 2 minutes of observation above each subsequent site of potential dynamic airway collapse (the velum, oropharynx/lateral walls, tongue base, epiglottis/supraglottis).

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Two recruitment scenarios are anticipated: 1) OHSU Patients who have previously been diagnosed with OSAS by polysomnography and are referred to Pediatric Otolaryngology for consideration of AT; 2) OHSU Patients referred to Pediatric Otolaryngology for consideration of AT for symptoms of sleep disordered breathing without a polysomnographic diagnosis of OSAS.

You may qualify if:

• Obesity (BMI \> 95th percentile or z-score \> 1.96 for age)
• Down syndrome
• African American race
• Pre-operative AHI \> 10
• Age \> 7 years
• Tonsils rated 1+ but persistent symptoms of OSA

You may not qualify if:

• Craniofacial anomalies (including cleft lip and palate, Pierre Robin sequence)
• Genetic abnormalities
• Neuromuscular disorders (including cerebral palsy, hypotonia)
• Subglottic or tracheal stenosis
• Tracheostomy dependence
• Severe cardiopulmonary disease requiring supplemental oxygen at night
• Primary caregiver(s) are unable to complete questionnaires in English or Spanish, cannot be reached by telephone, or are planning to move during the study period

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Doernbecher Children's Hospital

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Derek Lam, MD, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 29, 2016
• Study Start: February 1, 2015
• Primary Completion: November 9, 2022
• Study Completion: March 31, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)