Obstructive Sleep ApneaCHATNCT00560859

Childhood Adenotonsillectomy Study for Children With OSAS

A study testing Adenotonsillectomy (AT) - removal of adenoids and tonsils and Watchful Waiting in people with Obstructive Sleep Apnea and Snoring, run by University of Pennsylvania at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 5 to 9 years
Conditions the study is for: Obstructive Sleep Apnea, Snoring
What is being tested?: Adenotonsillectomy (AT) - removal of adenoids and tonsils and Watchful Waiting
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 453 participants
Where: 6 sitesUnited States
Study dates: Oct 2007to Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 to 9 years
All sexes
No healthy volunteers
Child

Who may be able to join

Ages 5.0 to 9.99 years at time of screening.
Diagnosed with Obstructive Sleep Apnea defined as: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 2, confirmed on nocturnal, laboratory-based PSG and Parental report of habitual snoring (on average occurring >3 nights per week).
Tonsillar hypertrophy ≥ 1 based on a standardized scale of 0-4: 0 = surgically absent, 1 = taking up < 25% of the airway, 2 = 25 - 50 % of the airway,3 = 50 - 75 % of the airway, 4 = > 75% of the airway
Deemed to be a surgical candidate for AT by Ear, Nose and Throat specialist (ENT) evaluation.

Who cannot join

Recurrent tonsillitis defined as: >3 episodes in each of 3 years, 5 episodes in each of 2 years, or 7 episodes in one year
Craniofacial anomalies, including cleft lip and palate or sub-mucosal cleft palate or any anatomic or systemic condition which would interfere with general anesthesia or removal of tonsils and adenoid tissue in the standard fashion
Obstructive breathing while awake that merits prompt AT in the opinion of the child's physician
Severe OSAS or significant hypoxemia requiring immediate AT as defined by: OAI>20 or AHI>30, desaturation defined as oxygen saturation (SaO2) <90% for more than 2% sleep time
Apnea hypopnea indices in the normal range (OAI < 1 and AHI <2)
Evidence of clinically significant cardiac arrhythmia on PSG: Non-sustained ventricular tachycardia Atrial fibrillation, Second degree atrioventricular (AV) block: Sustained bradycardia < 40 bpm (> 2 minutes, Sustained tachycardia > 140 bpm (> 2 minutes)

Show all 16Show fewer

Extremely overweight defined as: body mass index > 2.99 age group and sex-z-score
Severe health problems that could be exacerbated by delayed treatment for OSAS Including: Doctor-diagnosed heart disease or cor pulmonale, history of Stage II Hypertension (HTN) defined as > 99% percentile plus 5 mmHg for either systolic or diastolic, based on the age, gender, and height and/or requiring medication, therapy for failure to thrive or short stature, psychiatric or behavioral disorders requiring or likely to require initiation of new medication, therapy, or other specific treatment. School aged children, parental report of excessive daytime sleepiness defined as unable to maintain wakefulness, at least three times per week, in routine activities in school or home, despite adequate opportunity to sleep.
Severe chronic health conditions that might hamper participation including: severe cardiopulmonary disorders, sickle cell anemia, poorly controlled asthma, epilepsy requiring medication, diabetes (type I or type II) requiring medication, conditions likely to preclude accurate polysomnography (e.g. severe uncontrolled pain),mental retardation or enrollment in a formal school Individual Educational Plan (IEP) and assigned to a self-contained classroom for all academic subjects, history of inability to complete cognitive testing and/or score on the Differential Ability Scale (DAS) II of ≤ 55, chronic infection or HIV
Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition, or behavior
Current use of one or more of the following medications: psychotropics, hypnotics,hypoglycemic agents or insulin,antihypertensives,growth hormone, anticonvulsants,anti-coagulants,daily oral corticosteroids, daily medications for pain
Previous upper airway surgery on the nose, pharynx or larynx, including tonsillectomy. Ear surgery and/or pressure equalizing (PE) tubes are not exclusion criteria
Receives Continuous Positive Airway Pressure (CPAP) treatment
A parent or guardian who cannot accompany the child on the night of polysomnogram (PSG)
A family planning to move out of the area within the year
Female participants only: Parental report that child has reached menarche

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Children's Hospital Boston
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Montefiore Children's Hospital
New York, New York, 10467
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19401
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome

The purpose of this research is to determine the effect of adenotonsillectomy surgery (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children. OSAS can cause health problems including poor growth, high blood pressure, diabetes and behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve afterwards. This study will help determine if improvement occurs or if it does not. It will also look at whether certain groups, such as children who are overweight or of different ethnicities, are helped by the surgery.

Read the detailed description

Because adenotonsillectomy is the usual treatment for OSAS, all children in the study will get surgery. However, in order to assess the extent to which adenotonsillectomy surgery improves breathing disturbances and sleep quality in children with OSAS, two groups will be studied. One group will get surgery early (one month after enrollment) and the other group will be re-evaluated for surgery within 7 months of enrollment.

Children in both groups will be closely monitored through the 7-8 month study period and sleep and health educational materials will be provided to assist in establishing healthy habits.

Conditions: Obstructive Sleep Apnea, Snoring
Being tested: Adenotonsillectomy (AT) - removal of adenoids and tonsils, Watchful Waiting
Keywords: Sleep disordered breathing, Sleep apnea, Tonsillectomy, Adenoidectomy, Snoring, Neurobehavioral Manifestations, Obstructive Sleep Apnea Syndrome
Medical subject headings: Sleep Apnea, Obstructive, Snoring, Sleep Apnea Syndromes, Neurobehavioral Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adenotonsillectomy (AT) - removal of adenoids and tonsilsProcedure or surgery
Also called EAT
Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils
Watchful WaitingOther
Also called Watchful Waiting with Supportive Care (WWSC)
Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Study groups in NCT00560859
Study group	Role	What they receive
Early AT Surgery	Active comparator	There will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit. Receives: Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils
Watchful Waiting	Other	Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period. Receives: Other: Watchful Waiting

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.
The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.
Measured: The primary endpoint measure will occur at 7 months following the baseline visit.

Secondary outcomes (2)

Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months
The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.
Measured: 7 months following the baseline visit.
Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale
Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.
Measured: 7 months following baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Jun 2012

First posted20 Nov 2007 (estimated)
Study startOct 2007
Primary completionMar 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (31)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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
Masking: Single blind
Who is masked: Investigator
Enrolment: 453 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00560859
Sponsor's protocol ID: 804695
Other IDs: 5U01HL083129-05
Acronym: CHAT
Status last verified: Nov 2015
First submitted: 19 Nov 2007
Last updated: 15 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wang C, Wang A, Wu J, Wang Y. Risk Factors, Symptom Burden, and Treatment Response in Pediatric REM-Predominant OSA: Evidence From the Childhood Adenotonsillectomy Trial. Laryngoscope Investig Otolaryngol. 2026 Aug 2;11(4):e70524. doi: 10.1002/lio2.70524. eCollection 2026 Aug.
PubMed 42544299
Tsou PY, Alex RM, Redline S, Sands SA. Pathophysiological Traits in Pediatric Obstructive Sleep Apnea. Associations with Patient Characteristics and Responses to Therapy: A Secondary Analysis of the CHAT Clinical Trial. Ann Am Thorac Soc. 2025 Dec;22(12):1931-1941. doi: 10.1513/AnnalsATS.202412-1302OC.
PubMed 40720163
Ramirez-Contreras C, Elgueta VP, Briones-Suarez L. Childhood OSAS and Obesity: Prospective Associations of Anthropometric Markers With Objective Sleep Outcomes in the CHAT Trial. J Sleep Res. 2026 Apr;35(2):e70156. doi: 10.1111/jsr.70156. Epub 2025 Jul 17.
PubMed 40676770
Dai S, Yang M, Au CT, Yuen NTK, Zhang Y, Tang A, Yu MWL, Li AM, Chan KCC. Supine position-related obstructive sleep apnea in children: insights from the Childhood Adenotonsillectomy Trial. Sleep Breath. 2025 Jun 30;29(4):230. doi: 10.1007/s11325-025-03393-1.
PubMed 40587023
Wang C, Sun K, Liu K, Yu Z. Association of allergic rhinitis with persistent obstructive sleep apnea: A secondary analysis of the childhood adenotonsillectomy trial. Sleep Med. 2024 Mar;115:246-250. doi: 10.1016/j.sleep.2024.02.029. Epub 2024 Feb 15.
PubMed 38382311
Wang C, Hu H, Sun K, Ma Y, Lu Y, Liu K, Yu Z. Dysphagia Outcomes Before and After Adenotonsillectomy in Children With Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Oct 1;149(10):878-883. doi: 10.1001/jamaoto.2023.2145.
PubMed 37590002
Williamson AA, Fan J, Distel L, Xiao R, Stefanovski D, Tapia IE. Nighttime sleep duration and variability in children with obstructive sleep apnea syndrome: Sociodemographic disparities and neurobehavioral outcomes. Sleep Med. 2023 Feb;102:165-172. doi: 10.1016/j.sleep.2023.01.003. Epub 2023 Jan 10.
PubMed 36682144
Magnusdottir S, Witmans M, Hilmisson H. Sleep quality, sleep apnea, and metabolic health in children treated with adenotonsillectomy. Sleep Breath. 2023 Aug;27(4):1527-1540. doi: 10.1007/s11325-022-02747-3. Epub 2022 Nov 24.
PubMed 36434376
Yu PK, Radcliffe J, Gerry Taylor H, Amin RS, Baldassari CM, Boswick T, Chervin RD, Elden LM, Furth SL, Garetz SL, George A, Ishman SL, Kirkham EM, Liu C, Mitchell RB, Kamal Naqvi S, Rosen CL, Ross KR, Shah JR, Tapia IE, Young LR, Zopf DA, Wang R, Redline S. Neurobehavioral morbidity of pediatric mild sleep-disordered breathing and obstructive sleep apnea. Sleep. 2022 May 12;45(5):zsac035. doi: 10.1093/sleep/zsac035. Epub 2022 Feb 12.
PubMed 35554583
Snow A, Vazifedan T, Baldassari CM. Evaluation of Nocturnal Enuresis After Adenotonsillectomy in Children With Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Oct 1;147(10):887-892. doi: 10.1001/jamaoto.2021.2303.
PubMed 34499109
Martin-Montero A, Gutierrez-Tobal GC, Kheirandish-Gozal L, Vaquerizo-Villar F, Alvarez D, Del Campo F, Gozal D, Hornero R. Heart rate variability as a potential biomarker of pediatric obstructive sleep apnea resolution. Sleep. 2022 Feb 14;45(2):zsab214. doi: 10.1093/sleep/zsab214.
PubMed 34498074
Isaiah A, Spanier AJ, Grattan LM, Wang Y, Pereira KD. Predictors of Behavioral Changes After Adenotonsillectomy in Pediatric Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):900-908. doi: 10.1001/jamaoto.2020.2432.
PubMed 32880655
Hartmann S, Bruni O, Ferri R, Redline S, Baumert M. Cyclic alternating pattern in children with obstructive sleep apnea and its relationship with adenotonsillectomy, behavior, cognition, and quality of life. Sleep. 2021 Jan 21;44(1):zsaa145. doi: 10.1093/sleep/zsaa145.
PubMed 32777055
Hilmisson H, Berman S, Magnusdottir S. Sleep apnea diagnosis in children using software-generated apnea-hypopnea index (AHI) derived from data recorded with a single photoplethysmogram sensor (PPG) : Results from the Childhood Adenotonsillectomy Study (CHAT) based on cardiopulmonary coupling analysis. Sleep Breath. 2020 Dec;24(4):1739-1749. doi: 10.1007/s11325-020-02049-6. Epub 2020 Mar 28.
PubMed 32222900
Isaiah A, Pereira KD, Das G. Polysomnography and Treatment-Related Outcomes of Childhood Sleep Apnea. Pediatrics. 2019 Oct;144(4):e20191097. doi: 10.1542/peds.2019-1097.
PubMed 31533972

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 2
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Recruiting
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All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome
ClinicalTrials.gov ID: NCT00560859
Acronym / sponsor ID: CHAT / 804695
Conditions: Obstructive Sleep Apnea, Snoring
Keywords: Sleep disordered breathing, Sleep apnea, Tonsillectomy, Adenoidectomy, Snoring, Neurobehavioral Manifestations, Obstructive Sleep Apnea Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 453 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Harvard University, University of Michigan, National Heart, Lung, and Blood Institute (NHLBI)
Study start: Oct 2007
Primary completion: Mar 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 20 Nov 2007 (estimated)
Results: Posted 15 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Children in both groups will be closely monitored through the 7-8 month study period and sleep and health educational materials will be provided to assist in establishing healthy habits.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Early AT Surgery	Active comparator	Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsilsThere will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit.
Watchful Waiting	Other	Other: Watchful WaitingChildren will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.

Who may qualify

Ages: 5 to 9 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Ages 5.0 to 9.99 years at time of screening.
Diagnosed with Obstructive Sleep Apnea defined as: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 2, confirmed on nocturnal, laboratory-based PSG and Parental report of habitual snoring (on average occurring >3 nights per week).
Tonsillar hypertrophy ≥ 1 based on a standardized scale of 0-4: 0 = surgically absent, 1 = taking up < 25% of the airway, 2 = 25 - 50 % of the airway,3 = 50 - 75 % of the airway, 4 = > 75% of the airway
Deemed to be a surgical candidate for AT by Ear, Nose and Throat specialist (ENT) evaluation.

Key exclusion criteria (16 listed)

Recurrent tonsillitis defined as: >3 episodes in each of 3 years, 5 episodes in each of 2 years, or 7 episodes in one year
Craniofacial anomalies, including cleft lip and palate or sub-mucosal cleft palate or any anatomic or systemic condition which would interfere with general anesthesia or removal of tonsils and adenoid tissue in the standard fashion
Obstructive breathing while awake that merits prompt AT in the opinion of the child's physician
Severe OSAS or significant hypoxemia requiring immediate AT as defined by: OAI>20 or AHI>30, desaturation defined as oxygen saturation (SaO2) <90% for more than 2% sleep time
Apnea hypopnea indices in the normal range (OAI < 1 and AHI <2)

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
Adenotonsillectomy (AT) - removal of adenoids and tonsilsAlso: EATStandard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils	Procedure or surgery	Early AT Surgery
Watchful WaitingAlso: Watchful Waiting with Supportive Care (WWSC)Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.	Other	Watchful Waiting

Primary outcome

Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.
Time frame: The primary endpoint measure will occur at 7 months following the baseline visit.
The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.

2 secondary outcomes

Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months
Time frame: 7 months following the baseline visit.
Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale
Time frame: 7 months following baseline.

Results and safety

Results posted to the registry on 15 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early AT Surgery	226	194
Watchful Waiting	227	203

Primary outcome: Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.

Time frame: The primary endpoint measure will occur at 7 months following the baseline visit.. Mean (Standard Deviation). Unit: units on a scale

Measure	Early AT Surgery n = 194	Watchful Waiting n = 203
Value	7.1 (13.9)	5.1 (13.4)

Early AT Surgery vs Watchful Waiting: difference of change from baseline: 2.0, p = 0.16, ANCOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reported adverse events include events starting from the initiation of any study procedures to the end of the study follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early AT Surgery	7 of 226 (3.1%)	166 of 226 (73.5%)	Not reported
Watchful Waiting	9 of 227 (4%)	227 of 227 (100%)	Not reported

Limitations and caveats (from the sponsor): Children under 5 years of age, in whom OSAS is common, were not included. Children on medications for ADHD or with prolonged oxygen-hemoglobin desaturation were also excluded, so results cannot be extrapolated to such children.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42544299Wang C, Wang A, Wu J, Wang Y. Risk Factors, Symptom Burden, and Treatment Response in Pediatric REM-Predominant OSA: Evidence From the Childhood Adenotonsillectomy Trial. Laryngoscope Investig Otolaryngol. 2026 Aug 2;11(4):e70524. doi: 10.1002/lio2.70524. eCollection 2026 Aug.
Derived from this study: PubMed 40720163Tsou PY, Alex RM, Redline S, Sands SA. Pathophysiological Traits in Pediatric Obstructive Sleep Apnea. Associations with Patient Characteristics and Responses to Therapy: A Secondary Analysis of the CHAT Clinical Trial. Ann Am Thorac Soc. 2025 Dec;22(12):1931-1941. doi: 10.1513/AnnalsATS.202412-1302OC.
Derived from this study: PubMed 40676770Ramirez-Contreras C, Elgueta VP, Briones-Suarez L. Childhood OSAS and Obesity: Prospective Associations of Anthropometric Markers With Objective Sleep Outcomes in the CHAT Trial. J Sleep Res. 2026 Apr;35(2):e70156. doi: 10.1111/jsr.70156. Epub 2025 Jul 17.
Derived from this study: PubMed 40587023Dai S, Yang M, Au CT, Yuen NTK, Zhang Y, Tang A, Yu MWL, Li AM, Chan KCC. Supine position-related obstructive sleep apnea in children: insights from the Childhood Adenotonsillectomy Trial. Sleep Breath. 2025 Jun 30;29(4):230. doi: 10.1007/s11325-025-03393-1.
Derived from this study: PubMed 38382311Wang C, Sun K, Liu K, Yu Z. Association of allergic rhinitis with persistent obstructive sleep apnea: A secondary analysis of the childhood adenotonsillectomy trial. Sleep Med. 2024 Mar;115:246-250. doi: 10.1016/j.sleep.2024.02.029. Epub 2024 Feb 15.
Derived from this study: PubMed 37590002Wang C, Hu H, Sun K, Ma Y, Lu Y, Liu K, Yu Z. Dysphagia Outcomes Before and After Adenotonsillectomy in Children With Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2023 Oct 1;149(10):878-883. doi: 10.1001/jamaoto.2023.2145.
Derived from this study: PubMed 36682144Williamson AA, Fan J, Distel L, Xiao R, Stefanovski D, Tapia IE. Nighttime sleep duration and variability in children with obstructive sleep apnea syndrome: Sociodemographic disparities and neurobehavioral outcomes. Sleep Med. 2023 Feb;102:165-172. doi: 10.1016/j.sleep.2023.01.003. Epub 2023 Jan 10.
Derived from this study: PubMed 36434376Magnusdottir S, Witmans M, Hilmisson H. Sleep quality, sleep apnea, and metabolic health in children treated with adenotonsillectomy. Sleep Breath. 2023 Aug;27(4):1527-1540. doi: 10.1007/s11325-022-02747-3. Epub 2022 Nov 24.
Derived from this study: PubMed 35554583Yu PK, Radcliffe J, Gerry Taylor H, Amin RS, Baldassari CM, Boswick T, Chervin RD, Elden LM, Furth SL, Garetz SL, George A, Ishman SL, Kirkham EM, Liu C, Mitchell RB, Kamal Naqvi S, Rosen CL, Ross KR, Shah JR, Tapia IE, Young LR, Zopf DA, Wang R, Redline S. Neurobehavioral morbidity of pediatric mild sleep-disordered breathing and obstructive sleep apnea. Sleep. 2022 May 12;45(5):zsac035. doi: 10.1093/sleep/zsac035. Epub 2022 Feb 12.
Derived from this study: PubMed 34499109Snow A, Vazifedan T, Baldassari CM. Evaluation of Nocturnal Enuresis After Adenotonsillectomy in Children With Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Oct 1;147(10):887-892. doi: 10.1001/jamaoto.2021.2303.
Derived from this study: PubMed 34498074Martin-Montero A, Gutierrez-Tobal GC, Kheirandish-Gozal L, Vaquerizo-Villar F, Alvarez D, Del Campo F, Gozal D, Hornero R. Heart rate variability as a potential biomarker of pediatric obstructive sleep apnea resolution. Sleep. 2022 Feb 14;45(2):zsab214. doi: 10.1093/sleep/zsab214.
Derived from this study: PubMed 32880655Isaiah A, Spanier AJ, Grattan LM, Wang Y, Pereira KD. Predictors of Behavioral Changes After Adenotonsillectomy in Pediatric Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):900-908. doi: 10.1001/jamaoto.2020.2432.
National Center on Sleep Disorder ResearchLink provided by the sponsor.

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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. This study is not recruiting at the moment.

Susan Redline, MD, MPH study chair

Harvard University

Susan Ellenberg, Ph.D. study director

University of Pennsylvania

Ron Chervin, MD, MS principal investigator

University of Michigan

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. 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: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months. (time frame: The primary endpoint measure will occur at 7 months following the baseline visit.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00560859, which also lists 31 linked publications.

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 15 Dec 2015.