Personalized surgery versus tonsil removal for sleep apnea in children with Down syndrome

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children with Down syndrome who have moderate to severe obstructive sleep apnea (blocked breathing during sleep). It compares two types of surgery.

Age

Child aged 2.00 to 17.99 years. The caregiver must be 18 years or older.

Sex

All sexes

Disease stage

Moderate to severe obstructive sleep apnea shown by a sleep study (PSG), with oAHI ≥ 5. The child must be able to have surgery.

Earlier treatment

The child cannot have had a tonsillectomy, tonsillotomy or partial tonsillectomy before.

Biomarker or test result

Down syndrome (Trisomy 21).

Main reasons for not taking part

• Any reason the child cannot have surgery, such as a bleeding disorder
• Serious heart or lung disease besides sleep apnea that needs extra oxygen
• Narrowing of the windpipe below the vocal cords, or depending on a tracheostomy (breathing tube in the neck)
• Child is pregnant, has a child, or plans to have a child
• Caregiver cannot speak, read and write English or Spanish, or cannot follow study steps

This trial only enrols participants with Down syndrome. The registry sentence this rests on: Child has a diagnosis of Down syndrome (Trisomy 21).

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 2 and 17 years old?YesNo

What the trial wants to find out

The overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in the general pediatric population. Untreated OSA in children has been associated with daytime sleepiness, cognitive or behavioral problems, and cardiovascular complications, all which are common in children with DS. Adenotonsillectomy (AT) is the first line treatment for OSA in children, however, most large studies of AT outcomes have excluded children with DS. Available evidence demonstrates that AT is far less effective in children with DS than in the general pediatric population, with 48 to 95% of children with DS having persistent OSA after AT. Medical treatments such as positive airway pressure (PAP) therapy are frequently inadequate or poorly tolerated in this population, so many children with DS and OSA remain untreated. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of obstruction during sedated sleep using a flexible endoscope passed through the nose into the pharynx. DISE was developed to guide surgical decisions in adult OSA, and in recent years has also been used to design personalized surgical interventions in children. Using this DISE Rating Scale, the investigators have demonstrated that children with DS are more prone to tongue base and supraglottic obstruction than non-DS children, suggesting the need for more personalized surgical treatments that are tailored to the common sources of obstruction in this population. Several small case series demonstrate that DISE-directed surgery can be effective in treating OSA in children with DS. However, because there have been few prospective studies and no randomized trials comparing different treatment options in this population, there remains uncertainty about whether such a personalized approach leads to superior outcomes compared to the first line AT.

The 2 groups in the trial

• Drug-Induced Sleep EndoscopyTreatment being tested

  DISE will be performed at the time of surgery under the same sedation. The decision on specific surgical approach will be made at that time based on DISE findings. Prior to intubation, patients will be sedated with either a propofol infusion or a combination of ketamine and dexmedetomidine. Once adequate sedation is achieved, endoscopy will be performed using a flexible endoscope advanced through the nose. The nasal airway will be evaluated on both sides, then the endoscope will be advanced into the pharynx. The degree of obstruction is scored on a 3-point rating scale. Participants randomized to DISE-directed surgery will undergo one or more potential procedures in a single surgery. Caregivers will be consented for all possible procedures with the understanding that only those needed based on DISE will be performed. Importantly, these procedures are all established treatments with published outcomes data.

  Treatment: DISE-Directed Surgery

• AdenotonsillectomyExisting treatment, for comparison

  Adenotonsillar hypertrophy is the most common risk factor for OSA in children, and adenotonsillectomy (AT) is the first line treatment. An adenotonsillectomy is an operation to remove both the adenoids and tonsils.