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Personalized Surgery for Sleep Apnea in Down Syndrome (TOPS-DS Trial)

N/A

Waitlist Available

Led By Derek Lam, MD, MPH

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child age is 2.00 to 17.99 years of age

Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month follow up

Awards & highlights

TOPS-DS Trial Summary

This trial aims to compare the effectiveness of personalized DISE-directed surgery vs AT in children with Down syndrome and OSA, to determine the best treatment.

Who is the study for?

This trial is for children aged 2 to 17 with Down syndrome and moderate to severe obstructive sleep apnea (OSA), who haven't had tonsil surgery before. Caregivers must be able to communicate in English or Spanish, give consent, and commit to the study's procedures. Children with significant heart/lung issues besides OSA or conditions that make surgery risky are excluded.Check my eligibility

What is being tested?

The trial tests personalized surgical treatment for OSA against the standard adenotonsillectomy (AT) in kids with Down syndrome. It uses drug-induced sleep endoscopy (DISE) to tailor surgeries based on each child's specific airway blockages during sedated sleep.See study design

What are the potential side effects?

Surgical side effects may include pain, bleeding, infection risk at the operation site, breathing difficulties post-surgery, reactions from anesthesia used during DISE and surgery, and potential need for further interventions if initial surgery doesn't resolve OSA.

TOPS-DS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 2 and 17 years old.

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

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My child has Down syndrome.

TOPS-DS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline Polysomnography Measures: % Total Sleep Time with ETCO2 > 50 mmHg at 6 months

Change from Baseline Polysomnography Measures: AHI at 6 months

Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months

+4 more

Secondary outcome measures

Adverse Events

Change in Feeding and Swallowing Impact Survey (FSIS) Questionnaire Answers

Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire answers

+3 more

TOPS-DS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Drug-Induced Sleep EndoscopyExperimental Treatment1 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: AdenotonsillectomyActive Control1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

973 Previous Clinical Trials

7,385,509 Total Patients Enrolled

University of MichiganOTHER

1,797 Previous Clinical Trials

6,377,755 Total Patients Enrolled

Eastern Virginia Medical SchoolOTHER

69 Previous Clinical Trials

14,148 Total Patients Enrolled

Media Library

Adenotonsillectomy Clinical Trial Eligibility Overview. Trial Name: NCT05508971 — N/A

Obstructive Sleep Apnea Research Study Groups: Adenotonsillectomy, Drug-Induced Sleep Endoscopy

Obstructive Sleep Apnea Clinical Trial 2023: Adenotonsillectomy Highlights & Side Effects. Trial Name: NCT05508971 — N/A

Adenotonsillectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05508971 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range for this research project limited to those under twenty years?

"This research is enrolling participants between the ages of two and seventeen."

Answered by AI

Is enrollment for this trial still open?

"The records on clinicaltrials.gov suggest that patient recruitment for this particular research project has ceased since August 25th, 2023; however, there are 1694 other trials actively recruiting participants at the moment."

Answered by AI

What criteria must individuals meet in order to join this research trial?

"This medical trial seeks 303 individuals with obstructive sleep apnea between the ages of 2 and 17. To apply, candidates are required to have a diagnosis of Down syndrome (Trisomy 21), moderate to severe OSA diagnosed by PSG (oAHI ≥5). Moreover, applicants must be able to read, write and communicate in either English or Spanish; they must not be pregnant; and they should meet all criteria for surgical treatment as outlined in the study's description. Finally, only adults aged 18 years or older can provide consent on behalf of their child."

Answered by AI

What is the research team expecting to accomplish with this trial?

"This trial is designed to monitor the percentage of total sleep time with ETCO2 exceeding 50mmHg over a 6 month period following surgery. Secondary objectives include assessments in Disease-specific Quality of Life (OSA-18 Questionnaire), Generic Pediatric Quality of Life, and individual questions on QoL adjusted scores."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)

Derek Lam, MD, MPH 2023. "Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05508971.

All > Apnea > Down Syndrome