Obstructive Sleep ApneaTOPS-DSNCT05508971
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)
A study testing DISE-Directed Surgery and Adenotonsillectomy in people with Obstructive Sleep Apnea and Down Syndrome, run by Oregon Health and Science University at 7 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Obstructive Sleep Apnea, Down Syndrome
- What is being tested?
- DISE-Directed Surgery and Adenotonsillectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Aug 2023to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Requirements to participate in study:
Child has a diagnosis of Down syndrome (Trisomy 21). 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. 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 participate in 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.
Caregiver is unwilling or unable to comply with study procedures. Child is or plans to have their own child.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 6 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Brittany Nordhaus, nbrittan@med.umich.edu
Maelyn Fulton, maelyn@med.umich.edu
- Recruiting
Colorado Children's Hospital
Aurora, Colorado, 80045
Kari Gorecki, kari.gorecki@cuanschutz.edu
Norman Friedman, MD
- Terminated
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75235
Claudia Rivera, Claudia.Rivera2@UTSouthwestern.edu
Francesca Chambers, Francesca.Chambers@UTSouthwestern.edu
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Aaron Martinez, axmart26@texaschildrens.org
Nikhila Raol, MD
- Recruiting
EVMS Medical School
Norfolk, Virginia, 23507
Marysha Jones, JonesMJ@evms.edu
Lucky Enugu, enugul@evms.edu
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Eleni O'Neill, 503-875-9895, topsds@ohsu.edu
Derek Lam, MD, MPH
About this study
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.
It is the investigators' hypothesis that personalized DISE-directed surgery that uses existing procedures to address specific fixed and dynamic anatomic features causing obstruction in each child with DS will be superior to the current 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.
Read the detailed description
The overall objective of this randomized clinical trial is to test the effectiveness of a novel personalized approach to the surgical treatment of OSA in children with Down syndrome (DS). DS is a common disorder, affecting 1 in 691 births. 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 and behavioral problems, and cardiovascular complications, all of 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.
Pharyngeal hypotonia, unfavorable craniofacial anatomy, and adiposity are commonly cited risk factors for OSA and failure of AT in children with DS, however, there have been few attempts to characterize the pharyngeal anatomy or mechanisms of obstruction in this population. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of pharyngeal 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. To help standardize DISE assessments, the investigators previously developed and validated the DISE Rating Scale in children based on ordinal ratings of maximal airway obstruction (none, partial, complete) at six anatomic sites from the nose to the larynx. 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.
It is the investigators' central hypothesis that a personalized DISE-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction in each child with DS will be superior to the currently recommended 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 with DS and OSA ages 2-17 years with the following specific aims:
Aim 1: Compare the physiological outcomes of DISE-directed surgery vs AT in children with DS and OSA.
Hypothesis 1: DISE-directed surgery will result in a greater improvement in the obstructive apnea-hypopnea index compared to the standard AT intervention (effect size ≥ 0.36) after 6 months.
Aim 2: Compare the clinical outcomes of DISE-directed surgery vs AT in children with DS and OSA.
Hypothesis 2: DISE-directed surgery will result in a clinically significantly greater improvement (≥ 9 point improvement) in OSA-specific quality of life (OSA-18) compared to the standard AT intervention after 6 months. Secondarily, the investigators will test other clinical outcomes such as executive function (BRIEF2).
The investigators propose a randomized single-blind comparative effectiveness trial of AT vs DISE-directed sleep surgery for the treatment of OSA in children with DS (Figure 4). The investigators' primary hypothesis is that a personalized surgical intervention based on DISE findings will be more effective in treating OSA in children with DS than the standard AT. The first aim will compare the change in the obstructive apnea-hypopnea index (oAHI) between these treatment arms, and the second aim will compare the change in subjective measures of sleep apnea related quality of life (OSA-18) and executive function (BRIEF2). Outcomes will be assessed 6 months after surgery. The trial will be conducted at seven sites: Oregon Health and Science University, Cincinnati Children's Hospital and Medical Center, University of Michigan, University of Texas-Southwestern, Eastern Virginia Medical School, Texas Children's, and Children's Hospital Colorado.
- Conditions
- Obstructive Sleep Apnea, Down Syndrome
- Being tested
- DISE-Directed Surgery, Adenotonsillectomy
- Medical subject headings
- Sleep Apnea, Obstructive, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DISE-Directed SurgeryProcedure or surgery
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.
AdenotonsillectomyProcedure or surgery
Also called AT
Tonsil and adenoid removal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Adenotonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Polysomnography Measures: 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
Measured: 6 month follow up sleep study (after surgery)
Change from Baseline Polysomnography Measures: 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
Measured: 6 month follow up sleep study (after surgery)
Change from Baseline Polysomnography Measures: 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
Measured: 6 month follow up sleep study (after surgery)
Change from Baseline Polysomnography Measures: min 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
Measured: 6 month follow up sleep study (after surgery)
Change from Baseline Polysomnography Measures: desat index at 6 months
Oxyhemoglobin desaturation ≥ 3% Index: 6 months follow up sleep study difference from baseline sleep study
Measured: 6 month follow up sleep study (after surgery)
Change from Baseline Polysomnography Measures: % 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
Measured: 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
Measured: 6 month follow up sleep study (after surgery)
Secondary outcomes (6)
Change in Obstructive Sleep Apnea (OSA)-18 Questionnaire score
Disease specific quality of life measure: 18 questions, scores range from 18-126; higher scores means higher disease burden
Measured: 6 month follow up
Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire score
Generic quality of life measure: an age specific questionnaire with 23 questions (scores range from 0-100); higher scores indicate better quality of life.
Measured: 6 month follow up
Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire answers
Quality of life: questionnaire results by individual question. Adjusted scores range from 0-100; higher scores indicate better quality of life.
Measured: 6 month follow up
Total Drug induced sleep endoscopy (DISE) score
Subjective ratings of degree of obstruction at 6 levels of the upper airway, done by surgeon. Scores range from 0 to 12. Higher scores means more breathing obstruction, or more disease burden.
Measured: At time of surgery
Adverse Events
Did any adverse events occur in the post-operative time frame? This is a yes/no question, looking at the following outcomes: dehydration and poor oral intake due to post-operative pain, post-tonsillectomy hemorrhage, and respiratory compromise.
respiratory compromise.
Measured: 24 hour period after surgery
Change in Feeding and Swallowing Impact Survey (FSIS) Questionnaire Answers
Dysphagia specific quality of life measure: 18 questions, scores range from 18-90; higher scores means higher disease burden.
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start2 Aug 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be recruited from pediatric otolaryngology clinics. The study will be introduced to caregivers of children with DS and a history of sleep disordered breathing/OSA who are referred for surgery and meet the study participation 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 periop complications.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, University of Michigan, University of Texas, Eastern Virginia Medical School, National Heart, Lung, and Blood Institute (NHLBI), Baylor College of Medicine, Children's Hospital Colorado, Texas Children's Medical Center
- Responsible party
- Principal investigator, Derek Lam, MD, MPH, Oregon Health and Science University
- Investigators
- Derek Lam, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508971
- Sponsor's protocol ID
- STUDY00024746
- Other IDs
- 1R61HL165345
- Acronym
- TOPS-DS
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to researchers who are not primary researchers on this study.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)
- ClinicalTrials.gov ID
- NCT05508971
- Acronym / sponsor ID
- TOPS-DS / STUDY00024746
- Conditions
- Obstructive Sleep Apnea, Down Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, University of Michigan, University of Texas, Eastern Virginia Medical School, National Heart, Lung, and Blood Institute (NHLBI), Baylor College of Medicine, Children's Hospital Colorado, Texas Children's Medical Center
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
It is the investigators' hypothesis that personalized DISE-directed surgery that uses existing procedures to address specific fixed and dynamic anatomic features causing obstruction in each child with DS will be superior to the current 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.
Detailed description
The overall objective of this randomized clinical trial is to test the effectiveness of a novel personalized approach to the surgical treatment of OSA in children with Down syndrome (DS). DS is a common disorder, affecting 1 in 691 births. 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 and behavioral problems, and cardiovascular complications, all of 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.
Pharyngeal hypotonia, unfavorable craniofacial anatomy, and adiposity are commonly cited risk factors for OSA and failure of AT in children with DS, however, there have been few attempts to characterize the pharyngeal anatomy or mechanisms of obstruction in this population. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of pharyngeal 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. To help standardize DISE assessments, the investigators previously developed and validated the DISE Rating Scale in children based on ordinal ratings of maximal airway obstruction (none, partial, complete) at six anatomic sites from the nose to the larynx. 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.
It is the investigators' central hypothesis that a personalized DISE-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction in each child with DS will be superior to the currently recommended 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 with DS and OSA ages 2-17 years with the following specific aims:
Aim 1: Compare the physiological outcomes of DISE-directed surgery vs AT in children with DS and OSA.
Hypothesis 1: DISE-directed surgery will result in a greater improvement in the obstructive apnea-hypopnea index compared to the standard AT intervention (effect size ≥ 0.36) after 6 months.
Aim 2: Compare the clinical outcomes of DISE-directed surgery vs AT in children with DS and OSA.
Hypothesis 2: DISE-directed surgery will result in a clinically significantly greater improvement (≥ 9 point improvement) in OSA-specific quality of life (OSA-18) compared to the standard AT intervention after 6 months. Secondarily, the investigators will test other clinical outcomes such as executive function (BRIEF2).
The investigators propose a randomized single-blind comparative effectiveness trial of AT vs DISE-directed sleep surgery for the treatment of OSA in children with DS (Figure 4). The investigators' primary hypothesis is that a personalized surgical intervention based on DISE findings will be more effective in treating OSA in children with DS than the standard AT. The first aim will compare the change in the obstructive apnea-hypopnea index (oAHI) between these treatment arms, and the second aim will compare the change in subjective measures of sleep apnea related quality of life (OSA-18) and executive function (BRIEF2). Outcomes will be assessed 6 months after surgery. The trial will be conducted at seven sites: Oregon Health and Science University, Cincinnati Children's Hospital and Medical Center, University of Michigan, University of Texas-Southwestern, Eastern Virginia Medical School, Texas Children's, and Children's Hospital Colorado.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be recruited from pediatric otolaryngology clinics. The study will be introduced to caregivers of children with DS and a history of sleep disordered breathing/OSA who are referred for surgery and meet the study participation 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 periop complications.
| Arm | Type | Receives |
|---|---|---|
| Drug-Induced Sleep Endoscopy | Experimental | Procedure: DISE-Directed SurgeryDISE 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. |
| Adenotonsillectomy | Active comparator | Procedure: AdenotonsillectomyAdenotonsillar 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. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISE-Directed SurgeryParticipants 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. | Procedure or surgery | Drug-Induced Sleep Endoscopy |
| AdenotonsillectomyAlso: ATTonsil and adenoid removal | Procedure or surgery | Adenotonsillectomy |
Primary outcome
Change from Baseline Polysomnography Measures: oAHI at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): Obstructive Apnea-Hypopnea Index (oAHI): 6 months follow up sleep study difference from baseline sleep study
Change from Baseline Polysomnography Measures: AHI at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): Total Apnea-Hypopnea Index: 6 months follow up sleep study difference from baseline sleep study
Change from Baseline Polysomnography Measures: REM AHI at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): REM Apnea-Hypopnea Index REM AHI: 6 months follow up sleep study difference from baseline sleep study
Change from Baseline Polysomnography Measures: min SpO2 at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Objective results from sleep studies (polysomnography): Minimum Oxygen Saturation (Min SpO2): 6 months follow up sleep study difference from baseline sleep study
Change from Baseline Polysomnography Measures: desat index at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Oxyhemoglobin desaturation ≥ 3% Index: 6 months follow up sleep study difference from baseline sleep study
Change from Baseline Polysomnography Measures: % Total Sleep Time with ETCO2 > 50 mmHg at 6 months
Time frame: 6 month follow up sleep study (after surgery)
% Total Sleep Time with ETCO2 > 50 mmHg: 6 months follow up sleep study difference from baseline sleep study
Change from Baseline Polysomnography Measures: Max End Tidal CO2 (ETCO2) at 6 months
Time frame: 6 month follow up sleep study (after surgery)
Max End Tidal CO2 (ETCO2): 6 months follow up sleep study difference from baseline sleep study
6 secondary outcomes
Change in Obstructive Sleep Apnea (OSA)-18 Questionnaire score
Time frame: 6 month follow up
Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire score
Time frame: 6 month follow up
Change in Generic PedsQL (Pediatric Quality of Life) Questionnaire answers
Time frame: 6 month follow up
Total Drug induced sleep endoscopy (DISE) score
Time frame: At time of surgery
Adverse Events
Time frame: 24 hour period after surgery
Change in Feeding and Swallowing Impact Survey (FSIS) Questionnaire Answers
Time frame: 6 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be made available to researchers who are not primary researchers on this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Derek Lam, MD, MPH principal investigator
Oregon Health and Science University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DISE-Directed Surgery and Adenotonsillectomy in people with Obstructive Sleep Apnea and Down Syndrome, run by Oregon Health and Science University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleni O'Neill (503-875-9895, topsds@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Polysomnography Measures: oAHI at 6 months (time frame: 6 month follow up sleep study (after surgery)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.