Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils

NCT06258837 | Recruiting DMC

• 1 other identifier: STUDY00027270
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Otolaryngological Disease; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (7)

• Change from Baseline Polysomnography Measures: Obstructive Apnea-Hypopnea Index (oAHI) at 6 months

  Objective results from sleep studies (polysomnography): Obstructive Apnea-Hypopnea Index (oAHI): 6 months follow up sleep study difference from baseline sleep study. Higher scores indicate higher disease burden. Scores can range from zero to two hundred.

  6 month follow up sleep study (after surgery)

• Change from Baseline Polysomnography Measures: Total Apnea-Hypopnea Index (AHI) at 6 months

  Objective results from sleep studies (polysomnography): Total Apnea-Hypopnea Index: 6 months follow up sleep study difference from baseline sleep study. Higher scores indicate higher disease burden. Scores can range from zero to two hundred.

  6 month follow up sleep study (after surgery)

• Change from Baseline Polysomnography Measures: REM Apnea-Hypopnea Index (REM AHI) at 6 months

  Objective results from sleep studies (polysomnography): REM Apnea-Hypopnea Index REM AHI: 6 months follow up sleep study difference from baseline sleep study. Higher scores indicate higher disease burden. Scores can range from zero to two hundred.

  6 month follow up sleep study (after surgery)

• Change from Baseline Polysomnography Measures: minimum Oxygen saturation (SpO2) at 6 months

  Objective results from sleep studies (polysomnography): Minimum Oxygen Saturation (Min SpO2): 6 months follow up sleep study difference from baseline sleep study. Lower scores indicate higher disease burden. Scores range from 0-100, although neither extreme is actually seen in patients.

  6 month follow up sleep study (after surgery)

• Change from Baseline Polysomnography Measures: Oxyhemoglobin desaturation ≥ 3% Index (desat index) at 6 months

  Oxyhemoglobin desaturation ≥ 3% Index: 6 months follow up sleep study difference from baseline sleep study. Higher scores mean higher disease burden. Mild desaturation (\< 5.0 events/h), moderate desaturation (≥ 5.0 events/h and \< 10.0 events/h), and severe desaturation (≥ 10.0 events/h).

  6 month follow up sleep study (after surgery)

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

  % Total Sleep Time with ETCO2 \> 50 mmHg: 6 months follow up sleep study difference from baseline sleep study. Higher scores mean higher disease burden. Scores range from 0-100.

  6 month follow up sleep study (after surgery)

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

  Max End Tidal CO2 (ETCO2): 6 months follow up sleep study difference from baseline sleep study. Higher scores mean higher disease burden. Normal is 35-40 mmHg.

  6 month follow up sleep study (after surgery)

Secondary Outcomes (6)

• Change in Obstructive Sleep Apnea (OSA)-18 Questionnaire score

  6 month follow up

• Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire score

  6 month follow up

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

  6 month follow up

• Total Drug induced sleep endoscopy (DISE) score

  At time of surgery

• Adverse Events

  24 hour period after surgery

Study Arms (2)

Drug-Induced Sleep Endoscopy

EXPERIMENTAL

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.

Procedure: DISE-Directed Surgery

Adenotonsillectomy

ACTIVE COMPARATOR

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.

Procedure: Adenotonsillectomy

Interventions

DISE-Directed Surgery PROCEDURE

Participants randomized to DISE-directed surgery will undergo one or more potential procedures in a single surgery (i.e. DISE and subsequent sleep surgery performed) concurrently under the same general anesthetic), depending on anatomic assessment.

Also known as: sleep endoscopy

Drug-Induced Sleep Endoscopy

Adenotonsillectomy PROCEDURE

Tonsil and/or adenoid removal

Also known as: AT

Adenotonsillectomy

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

To be in the study: * Child has a diagnosis of moderate to severe OSA diagnosed by PSG (oAHI ≥ 5). * Child age is 2.00 to 17.99 years of age. * Child has small tonsils (Brodsky 1+ or 2+) noted during routine physical exam. * Caregiver can provide signed and dated consent and is 18 years of age or older at the time of consent. * Caregiver can speak, read, and write in English or Spanish. * Caregiver is primary caretaker of the child. * Child is not expecting their own child. * Child is eligible for surgical treatment Cannot be in the study if: * Child has history of previous tonsillectomy, tonsillotomy, or partial tonsillectomy. * Child has any contraindication to surgery (e.g. bleeding disorders). * Child has significant cardiopulmonary comorbidity besides OSA requiring supplemental oxygen, subglottic or tracheal stenosis, tracheostomy dependence. * Child has a genetic abnormality, Down syndrome, neuromuscular disorder, craniofacial anomaly. * Caregiver is unwilling or unable to comply with study procedures. * Child is or plans to become a parent themselves.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Michigan: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Otorhinolaryngologic Diseases; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Derek Lam, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni O'Neill

CONTACT

503-494-3569; oneilele@ohsu.edu

Derek Lam, MD

CONTACT

503-494-9419; lamde@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is not practical or feasible to maintain blinding among the surgeons performing the procedures or the clinical staff caring for patients in the perioperative setting. Given this, it is unlikely that blinding could be maintained among parents or caregivers of patients, therefore there will be no attempt to blind caregivers to the treatment assignment. However, the sleep medicine collaborators who will be reviewing and scoring postoperative PSGs will be instructed not to review the medical record so as to ensure blinding to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Otolaryngology-Head and Neck Surgery

Model Details: Participants will be recruited from pediatric otolaryngology clinics. The study will be introduced to caregivers of children with small tonsils and a history of sleep disordered breathing/OSA who are referred for surgery and meet the inclusion and exclusion criteria noted. If current or recent PSG testing demonstrates OSA, they will be invited to participate. Randomization will be done. Patients will be randomized to either the personalized DISE-directed surgery or the standard AT after collection of baseline measures and pre-op PSG. Allocation will be made by using a computer-generated randomization scheme. Caregivers will be advised of the outcomes and risks of different surgical procedures included in DISE-directed surgery and informed consent will be obtained. All patients will be planned for overnight observation to monitor for safety and perioperative complications.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)