Personalized Surgery for Obstructive Sleep Apnea

(TOPS-ST Trial)

Recruiting at 1 trial location

Overseen By Eleni O'Neill

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Previous tonsillectomy, Bleeding disorders, Cardiopulmonary comorbidity, Genetic abnormality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate (surgery day)

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new personalized surgery for children with obstructive sleep apnea (OSA) who have small tonsils. Instead of the usual removal of tonsils and adenoids, doctors will use drug-induced sleep endoscopy (DISE) to determine the best surgical steps based on individual needs. This method is known as DISE-Directed Surgery. The goal is to assess whether this personalized surgery leads to better sleep outcomes compared to the standard method. Children with moderate to severe sleep apnea and small tonsils may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative surgical techniques that could significantly improve sleep quality for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this personalized surgical approach is safe for children with obstructive sleep apnea?

Research has shown that DISE-directed surgery for obstructive sleep apnea (OSA) in children is generally safe. This method enables doctors to create personalized treatment plans by targeting specific areas causing airway blockage. Studies have found that children undergoing DISE-directed surgery often experience better results, with serious side effects being rare.

The steps involved in DISE-directed surgery are well-documented, with evidence supporting their safety and effectiveness. This approach is particularly beneficial for children with complex OSA, as it allows for customized surgical plans tailored to each child's unique needs. Parents and caregivers can feel reassured by the strong safety record of these procedures in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about DISE-directed surgery for obstructive sleep apnea (OSA) because it offers a personalized surgical approach. Unlike the standard adenotonsillectomy, which is a one-size-fits-all procedure, DISE-directed surgery uses drug-induced sleep endoscopy to evaluate the specific areas of obstruction in the airway. This allows surgeons to tailor the surgical approach in real-time, addressing each patient’s unique anatomical issues. By customizing the surgery, it has the potential to improve outcomes and reduce unnecessary procedures.

What evidence suggests that this trial's treatments could be effective for obstructive sleep apnea?

This trial compares two surgical approaches for treating obstructive sleep apnea (OSA) in children. One group will undergo adenotonsillectomy, the standard treatment for OSA caused by adenotonsillar hypertrophy. Another group will receive a personalized approach using drug-induced sleep endoscopy (DISE) to pinpoint the exact location of the airway blockage. Studies have suggested that DISE-directed surgery, which targets the specific blockage, can improve OSA symptoms more effectively than traditional methods. This approach has been particularly successful for children with blockages caused by the tongue, although results can vary based on each child's needs. Overall, this method aims to customize treatment for each child's unique airway issues, potentially reducing the need for additional surgeries. ^{1 3 4 5 6}

Who Is on the Research Team?

Derek Lam, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for children aged 2-17 years who have obstructive sleep apnea (OSA) but small tonsils. They should not have had previous surgery for OSA. The study aims to find a better surgical treatment tailored to each child's specific anatomy.

Inclusion Criteria

My child is a candidate for surgery.

Child has small tonsils (Brodsky 1+ or 2+) noted during routine physical exam

Caregiver is primary caretaker of the child

Exclusion Criteria

Caregiver is unwilling or unable to comply with study procedures

Child is or plans to become pregnant

My child has a genetic condition like Down syndrome or a neuromuscular disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either adenotonsillectomy or DISE-directed surgery based on randomization

Immediate (surgery day)

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for adverse events such as dehydration, poor oral intake, post-tonsillectomy hemorrhage, and respiratory compromise

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including polysomnography and quality of life assessments

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• DISE-Directed Surgery

Trial Overview The study compares two surgeries: a personalized approach using drug-induced sleep endoscopy (DISE) to tailor the surgery to the child's needs, and the standard adenotonsillectomy (AT), which removes tonsils and adenoids.

How Is the Trial Designed?

Group I: Drug-Induced Sleep Endoscopy Experimental Treatment 1 Intervention

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.

Group II: Adenotonsillectomy Active Control 1 Intervention

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.

DISE-Directed Surgery is already approved in United States for the following indications:

Approved in United States as DISE-Directed Surgery for:

• Treatment of Obstructive Sleep Apnea in Children with Down Syndrome

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

In a study of children with small tonsils, DISE-directed surgery significantly improved the apnea-hypopnea index (AHI) from an average of 14.4 to 8.0, indicating better sleep apnea outcomes after surgery.

The most common surgical intervention performed was supraglottoplasty, highlighting its importance in treating sleep apnea in this population, while adenotonsillectomy was rarely used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polysomnography outcomes in children with small tonsils undergoing drug-induced sleep endoscopy-directed surgery. Miller, C., Kirkham, E., Ma, CC., et al.[2020]

In a study of 24 children with Down Syndrome and obstructive sleep apnea who underwent drug-induced sleep endoscopy (DISE)-directed surgery, improvements were noted in all polysomnography (PSG) parameters, indicating potential benefits of this surgical approach.

The most significant improvement was observed in the oxygen nadir for children who had previously undergone adenotonsillectomy, suggesting that DISE-directed surgery can enhance oxygen levels during sleep in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does drug induced sleep endoscopy-directed surgery improve polysomnography measures in children with Down Syndrome and obstructive sleep apnea? Akkina, SR., Ma, CC., Kirkham, EM., et al.[2019]

In a study of 16 children with Down syndrome who had persistent obstructive sleep apnea (OSA) after adenotonsillectomy, drug-induced sleep endoscopy (DISE) effectively identified the sites of airway obstruction, allowing for targeted surgical interventions.

Post-operative results showed significant improvements in sleep apnea parameters, with 44% of the patients achieving normalization of their apnea-hypopnea index, indicating that DISE-directed treatment is a promising option for managing persistent OSA in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent Obstructive Sleep Apnea in Children with Down Syndrome After Adenotonsillectomy: Drug Induced Sleep Endoscopy-Directed Treatment. Abdel-Aziz, M., Abdel-Naseer, U., Elshahawy, E., et al.[2022]

In a study of 56 children with obstructive sleep apnea (OSA), those who underwent drug-induced sleep endoscopy (DISE)-directed surgery showed a significant improvement in their obstructive Apnea-Hypopnea Index (oAHI), with 54% achieving an oAHI of less than 5 events per hour post-surgery.

The study found that while various surgical procedures were performed, only the race of the children (specifically white race) was a significant predictor of achieving a successful outcome (oAHI <5) after the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Drug-Induced Sleep Endoscopy-Directed Surgery for Pediatric Obstructive Sleep Apnea. He, S., Peddireddy, NS., Smith, DF., et al.[2019]

Drug-induced sleep endoscopy (DISE) effectively identifies obstruction sites in children with obstructive sleep-disordered breathing (OSAS), with the oropharynx being the most common site of obstruction, especially in moderate to severe cases.

DISE led to a change in the initial treatment plan for 20% of the children studied, highlighting its potential to improve treatment recommendations based on individual obstruction patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The impact of sleep endoscopy for obstructive sleep-disordered breathing in children and adolescents]. Quante, M., Merkenschlager, A., Kiess, W., et al.[2014]

Drug induced sleep endoscopy (DISE) significantly influenced surgical decisions in pediatric patients with obstructive sleep apnea (OSA), leading to targeted interventions based on observed areas of obstruction, primarily the soft palate.

Post-operative results showed a significant reduction in the apnea-hypopnea index (AHI) from a mean of 21.3 to 7.6, indicating improved breathing patterns after surgery, suggesting that DISE may enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of drug induced sleep endoscopy on intraoperative decision making in pediatric sleep surgery. Dmowska, J., Larson, SR., Gillespie, MB., et al.[2020]

Citations

1. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/10698151

Treatment of Obstructive Sleep Apnea with ... - NIH RePORTER Several small case series demonstrate that personalized DISE-directed surgery can be effective in treating OSA in children with DS. Because there have been ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05508971

Treatment of Obstructive Sleep Apnea With Personalized ... The investigators propose a randomized single-blind comparative effectiveness trial of AT vs DISE-directed sleep surgery for the treatment of OSA in children ...

3. mdpi.com mdpi.com/2227-9067/12/9/1185

Outcomes of DISE-Directed Surgery for Obstructive Sleep ... Tongue-base reduction had the highest rate of improvement among DISE-guided interventions, while children with Trisomy 21 showed limited benefit. What is the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6813773/

Does Drug Induced Sleep Endoscopy-directed surgery ... DISE-directed surgery may be beneficial for children with DS and OSA, with improvement in the means of main PSG measures observed.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016558762030625X

Outcome of drug induced sleep endoscopy directed ... DISE directed surgery has shown to have changed surgical management in most studies. Introduction. Obstructive sleep apnoea (OSA) is part of the broad family of ...

6. reporter.nih.gov reporter.nih.gov/project-details/10972917

Treatment of Obstructive Sleep Apnea with ... - NIH RePORTER Several small case series demonstrate that personalized DISE-directed surgery can be effective in treating OSA in children with DS. Because there have been few ...