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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils (ST). This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months. It is the investigators' central hypothesis that a personalized drug-induced sleep endoscopy (DISE)-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction (ie, anatomic endotypes) in each child with ST will perform better than the currently recommended standard first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT. To test this hypothesis, the investigators propose to study children aged 2-17 years with small tonsils and OSA.

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 data supports the effectiveness of the treatment DISE-Directed Surgery for Obstructive Sleep Apnea in children with Down Syndrome?

Research shows that DISE-directed surgery can significantly improve sleep apnea in children with Down Syndrome, especially when other treatments like adenotonsillectomy have not fully worked. Studies found that after DISE-directed surgery, many children had better sleep study results, with some achieving normal levels of breathing interruptions during sleep. ^{1 2 3 4 5}

Is DISE-directed surgery safe for treating obstructive sleep apnea in children?

The studies on DISE-directed surgery for children with obstructive sleep apnea, including those with Down Syndrome, do not report any specific safety concerns, suggesting it is generally safe. However, as with any surgery, there may be risks, and it's important to discuss these with a healthcare provider. ^{1 2 3 4 6}

How is the treatment DISE-directed surgery unique for obstructive sleep apnea in children?

DISE-directed surgery is unique because it uses drug-induced sleep endoscopy to identify the specific sites of airway obstruction in children with obstructive sleep apnea, allowing for personalized surgical interventions. This approach is particularly beneficial for children with Down Syndrome or those who have persistent sleep apnea after other surgeries, as it tailors the treatment to the individual's specific needs. ^{1 2 3 4 6}

Research Team

Derek Lam, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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.

My child has been diagnosed with moderate to severe sleep apnea.

My child is between 2 and 17 years old.

Exclusion Criteria

Caregiver is unwilling or unable to comply with study procedures

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

Child is or plans to become pregnant

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Polysomnography outcomes in children with small tonsils undergoing drug-induced sleep endoscopy-directed surgery. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Does drug induced sleep endoscopy-directed surgery improve polysomnography measures in children with Down Syndrome and obstructive sleep apnea? [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Persistent Obstructive Sleep Apnea in Children with Down Syndrome After Adenotonsillectomy: Drug Induced Sleep Endoscopy-Directed Treatment. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Outcomes of Drug-Induced Sleep Endoscopy-Directed Surgery for Pediatric Obstructive Sleep Apnea. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[The impact of sleep endoscopy for obstructive sleep-disordered breathing in children and adolescents]. [2014]

6. Ireland pubmed.ncbi.nlm.nih.gov

Effect of drug induced sleep endoscopy on intraoperative decision making in pediatric sleep surgery. [2020]