Sleep-Disordered Breathing
Conditions
Keywords
Pediatrics, Primary Snoring, Adenotonsillectomy
Brief summary
The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.
Detailed description
Adenotonsillectomies are performed more than 500,000 times per year in the United States, and is the most common surgery performed under general anesthesia in children. The majority of surgeries are performed for obstructed breathing rather than for infection or other indications. The role of adenotonsillectomy (AT) in improving the 7-month neurocognitive, behavioral and health outcomes of children with frank obstructive sleep apnea (OSA) was recently addressed in the Childhood Adenotonsillectomy Trial (CHAT). The results of this rigorous, multicenter, randomized controlled trial provided critically important data indicating that adenotonsillectomy compared to watchful waiting resulted in improved behavior, quality of life, sleep-disordered breathing (SDB) symptoms and polysomnographic parameters. However, the Childhood Adenotonsillectomy Trial addressed the role of surgery in the minority of operative candidates who have frank obstructive sleep apnea, only one form of sleep disordered breathing on a spectrum that includes a more common phenotype, primary snoring (also termed mild sleep disordered breathing (MSDB)). Mild sleep disordered breathing is characterized by snoring without frank obstruction or gas exchange abnormalities, and has a population prevalence of about 10% in children. Since most surgeries for obstructed breathing are performed for mild sleep disordered breathing rather than obstructive sleep apnea, the next logical question is whether surgery is also effective in improving symptoms and health outcomes in this large group of children. The Pediatric Adenotonsillectomy Trial for Snoring (PATS) intends to take advantage of a successful collaboration of leaders in sleep medicine, otolaryngology and clinical trials to efficiently leverage experiences from the CHAT trial to evaluate the role of adenotonsillectomy in children with mild sleep disordered breathing while also aiming to resolve uncertainties regarding management approaches for pediatric mild sleep disordered breathing by addressing several critical issues: 1. Assess outcomes important to children and their families, particularly patient-reported outcomes such as behavior, quality of life, and sleep disturbances. 2. Examine differences in treatment responses among children who are at increased risk for mild sleep disordered breathing, such as pre-school children, minorities, and children with asthma or obesity. 3. Evaluate health care utilization of children with mild sleep disordered breathing. 4. Assess moderating influences such as second hand smoke, insufficient sleep, socioeconomic status and family functioning 5. Examine longer term (12 month) outcomes that were not feasible in the Childhood Adenotonsillectomy Trial (CHAT). These aims have substantial public health significance given the high morbidity of sleep disordered breathing in children.
Interventions
PROCEDUREEarly Adenotonsillectomy (eAT)
Standard clinical adenotonsillectomy within 4 weeks post randomization in addition to information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
BEHAVIORALWatchful Waiting with Supportive Care (WWSC)
Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
Sponsors
Children's Hospital of Philadelphia
University Hospitals Cleveland Medical Center
Children's Hospital Medical Center, Cincinnati
University of Michigan
University of Texas Southwestern Medical Center
University of Rochester
Children's Hospital of The King's Daughters
Boston Children's Hospital
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of mild sleep-disordered breathing (MSDB) defined as meeting all of the following criteria: * Caregiver report of habitual snoring that occurs most of the night on at least three nights per week, and has been present for at least three months (on average occurring \> 3 nights per week or more half of sleep time) and * Centrally-scored polysomnogram (PSG) confirming an obstructive apnea index (OAI) \<1/hour and apnea-hypopnea index (AHI) ≤3/hour and no oxygen saturation (SpO2) desaturation \< 90% in conjunction with obstructive events, confirmed on PSG. * Tonsillar hypertrophy ≥2 based on a standardized scale of 0-4. * Deemed to be a candidate for AT by otolaryngologist (ENT) evaluation (i.e., no technical issues that would be a contraindication for surgery such as submucous cleft palate.) * Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications).
Exclusion criteria
* Previous tonsillectomy, including partial tonsillectomy * Recurrent tonsillitis that merits prompt adenotonsillectomy (AT) per the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines (i.e., ≥7 episodes/yr in the past year; ≥5 episodes/year over the past 2 years or ≥3 episodes/yr over the past 3 years.) * Severe obesity (body mass index (BMI) z-score ≥3). * Failure to thrive, defined as either height or weight being below the 5th percentile for age and gender. * Severe chronic health conditions that might hamper participation or confound key variables under study, including but not limited to: * Severe cardiopulmonary disorders such as cystic fibrosis, and congenital heart disease. * Bleeding disorders * Sickle Cell Disease * Epilepsy requiring medication * Significant cardiac arrhythmia noted on PSG including: non-sustained ventricular tachycardia, atrial fibrillation, second degree atrioventricular block, sustained bradycardia, or sustained tachycardia. * Other severe chronic health problems such as diabetes, narcolepsy, and poorly controlled asthma. * Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition or behavior; * Current use of psychotropic medication (other than medications for attention deficit hyperactivity disorder, hypnotics, antihypertensives, hypoglycemic agents including insulin, anticonvulsants, anticoagulants, or growth hormone. * Diagnosis of autism spectrum disorder. * Intellectual deficit or assigned to a self-contained classroom for all academic subjects. * History of severe developmental disability or Adaptive Behavior Assessment System (ABAS-3) score ≤60. * Children/caregivers planning to move out of the area within the year. * Children in foster care. * Children/caregivers who do not speak English or Spanish well enough to complete the neurobehavioral measures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score | 12 months | The BRIEF GEC section comprises summary measures of behavioral regulation, emotion regulation, and cognitive regulation (BRIEF-2, for children aged 5 to 18 years) or inhibitory self-control, flexibility, and emergent metacognition (BRIEF-P, for preschool-aged children). These scores are linear transformations of the raw scores (mean = 50, sd = 10) where a higher T score indicates a child has a lower capacity to organize and self-regulate. |
| Change From Baseline to 12 Months in Go-No-Go (GNG) Signal Detection Parameter D-prime (d'). | 12 months | Performance on combined Go-No-Go (GNG)/Continuous Performance Test (CPT) task was assessed by tracking accuracy responses to targets (fish) and false positive responses to non-targets (sharks). d' is computed for both portions of the task as an assessment of accuracy in making correct detections adjusting for the participant's tendency to respond to non-targets. The adjusted measure is computed by subtracting Z-scores for false positive responses from Z-scores for correct detections. Individual Z-scores were based on a child's performance within same age groups (3-4, 5-6 , and \>=7 years old). Scores ranged across age groups from -0.53 to 3.99 for GNG and -0.61 to 4.35 for CPT. Higher scores reflect better discrimination of targets from non-targets. A value of 4.65 represents 100% accuracy, 0 represents chance performance, and minus scores represent more frequent detection of non-targets than targets, suggesting a child misunderstood instructions or preferred responding to non-targets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Months in Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorder Scale (PSQ-SRBD) Total Score. | 12 months | The PSQ-SRBD scale is a 22-item questionnaire which includes three subscales: snoring, daytime sleepiness, and hyperactive behaviors/inattention. The PSQ-SRBD is commonly used to assess sleep-disordered breathing (SDB) risk in pediatric patients, but is also increasingly used to assess symptom burden. Higher scores correspond to greater SDB symptoms and the total range is 0-1 |
| Change From Baseline to 12 Months in Sleepiness Measured by Change in the Epworth Sleepiness Scale (ESS) Modified for Children Summary Score. | 12 months | The Epworth Sleepiness Scale (ESS) Modified for Children is an 8-item validated questionnaire which evaluates excessive daytime sleepiness. The wording and questions are revised from the original ESS to be more suitable for children. The total score has a range from 0-24 where higher values indicate greater sleepiness. |
| Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. | 12 months | General quality of life assessed by caregiver reported PedsQL total score and subscores (Psychosocial Health Summary Score & Physical Health Summary Score). The PedsQL Total Score comprises performance on 4 subscales: emotional functioning, social functioning, school functioning (summarized by the Psychosocial Functioning Score) and physical functioning (summarized by the Physical Functioning score). Scores on all scales range from 0 to 100, with higher scores indicating an increased quality of life. |
| Change From Baseline to 12 Months in NIH-Toolbox 9-Hole Pegboard Dexterity Test Time | 12 months | Fine motor coordination assessed by the time (in seconds) it takes a child to complete the NIH-Toolbox 9-Hole Pegboard Dexterity Test. Shorter times indicate greater dexterity. The reported value is the average of the dominant and non-dominant hand scores. |
| Change From Baseline to 12 Months in Body Mass Index (BMI) Percentile | 12 months | Body Mass Index (BMI) percentile, calculated from the average of triplicate in-clinic height/weight measurements. Percentiles calculated from Centers for Disease Control and Prevention (CDC) BMI-for-age charts. |
| Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores. | 12 months | Mean of blood pressures measured in triplicate (to 1.0 mmHg) via automated oscillometric blood pressure cuff. Percentiles calculated respective to height, age and sex (PMID: 18230679). |
| Change From Baseline to 12 Months in Average Heart Rate | 12 months | Average heart rate (beats per minute) calculated from overnight polysomnography |
| Change From Baseline to 12 Months in Quality of Life Survey Evaluation of Sleep-Disordered Breathing (OSA-18) Total Score. | 12 months | The OSA-18 is a disease-specific QOL survey that captures symptoms across five domains: sleep disturbance, physical suffering, emotional distress, daytime problems, and parent/caretaker concerns. With a Likert 7-point scale, caregivers rate the perceived frequency of 18 OSA-related problems ranging from 1 (none of the time) to 7 (all the time). Scores on each item are summed to produce a total score ranging from 18 to 126. Higher scores correspond to poorer sleep disordered breathing-related QOL, with a score greater than or equal to 60 signifying a clinically meaningful negative impact of sleep disordered breathing on QOL |
| Change From Baseline to 12 Months in Child Behavior Checklist (CBCL) Summary Scale T Scores | 12 months | Behavior assessed by the change from baseline to 12 months in the caregiver-reported Child Behavior Checklist (CBCL) overall summary score T scores. The T scores are standardized transformations of the raw score (mean = 50, sd = 10), where a higher scores indicate greater problems. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Watchful Waiting With Supportive Care All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities. | 227 |
| Early Adenotonsillectomy All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities | 231 |
| Total | 458 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 20 | 28 |
| Overall Study | Withdrawal by Subject | 8 | 7 |
Baseline characteristics
| Characteristic | Early Adenotonsillectomy | Watchful Waiting With Supportive Care | Total |
|---|---|---|---|
| Age, Continuous | 6.10 years STANDARD_DEVIATION 2.25 | 6.15 years STANDARD_DEVIATION 2.36 | 6.13 years STANDARD_DEVIATION 2.3 |
| Apnea-Hypopnea Index | 0.5 events per hour | 0.6 events per hour | 0.5 events per hour |
| Asthma | 53 Participants | 55 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 33 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 189 Participants | 194 Participants | 383 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants | 63 Participants | 123 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 155 Participants | 148 Participants | 303 Participants |
| Sex: Female, Male Female | 119 Participants | 111 Participants | 230 Participants |
| Sex: Female, Male Male | 112 Participants | 116 Participants | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 228 | 0 / 231 |
| other Total, other adverse events | 112 / 228 | 103 / 231 |
| serious Total, serious adverse events | 9 / 228 | 13 / 231 |
Outcome results
Primary
Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score
The BRIEF GEC section comprises summary measures of behavioral regulation, emotion regulation, and cognitive regulation (BRIEF-2, for children aged 5 to 18 years) or inhibitory self-control, flexibility, and emergent metacognition (BRIEF-P, for preschool-aged children). These scores are linear transformations of the raw scores (mean = 50, sd = 10) where a higher T score indicates a child has a lower capacity to organize and self-regulate.
Time frame: 12 months
Population: All participants with valid measurements at both baseline and 12-months are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score | -1.90 change in score on a scale | Standard Deviation 8.62 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Caregiver-reported Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite (GEC) T Score | -3.08 change in score on a scale | Standard Deviation 9.39 |
Primary
Change From Baseline to 12 Months in Go-No-Go (GNG) Signal Detection Parameter D-prime (d').
Performance on combined Go-No-Go (GNG)/Continuous Performance Test (CPT) task was assessed by tracking accuracy responses to targets (fish) and false positive responses to non-targets (sharks). d' is computed for both portions of the task as an assessment of accuracy in making correct detections adjusting for the participant's tendency to respond to non-targets. The adjusted measure is computed by subtracting Z-scores for false positive responses from Z-scores for correct detections. Individual Z-scores were based on a child's performance within same age groups (3-4, 5-6 , and \>=7 years old). Scores ranged across age groups from -0.53 to 3.99 for GNG and -0.61 to 4.35 for CPT. Higher scores reflect better discrimination of targets from non-targets. A value of 4.65 represents 100% accuracy, 0 represents chance performance, and minus scores represent more frequent detection of non-targets than targets, suggesting a child misunderstood instructions or preferred responding to non-targets.
Time frame: 12 months
Population: All participants with valid measurements at both baseline and 12-months are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Go-No-Go (GNG) Signal Detection Parameter D-prime (d'). | 1.9 d-prime | Standard Deviation 8.6 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Go-No-Go (GNG) Signal Detection Parameter D-prime (d'). | 3.1 d-prime | Standard Deviation 9.4 |
Secondary
Change From Baseline to 12 Months in Average Heart Rate
Average heart rate (beats per minute) calculated from overnight polysomnography
Time frame: 12 months
Population: All participants with valid measurements at both baseline and 12-months are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Average Heart Rate | -1.80 change in avg bpm | Standard Deviation 7.92 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Average Heart Rate | -1.97 change in avg bpm | Standard Deviation 7.68 |
Secondary
Change From Baseline to 12 Months in Body Mass Index (BMI) Percentile
Body Mass Index (BMI) percentile, calculated from the average of triplicate in-clinic height/weight measurements. Percentiles calculated from Centers for Disease Control and Prevention (CDC) BMI-for-age charts.
Time frame: 12 months
Population: All participants with 3 valid height and weight measurements at both baseline and 12-months are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Body Mass Index (BMI) Percentile | 3.23 change in percentile | Standard Deviation 13.31 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Body Mass Index (BMI) Percentile | 5.09 change in percentile | Standard Deviation 14.32 |
Secondary
Change From Baseline to 12 Months in Child Behavior Checklist (CBCL) Summary Scale T Scores
Behavior assessed by the change from baseline to 12 months in the caregiver-reported Child Behavior Checklist (CBCL) overall summary score T scores. The T scores are standardized transformations of the raw score (mean = 50, sd = 10), where a higher scores indicate greater problems.
Time frame: 12 months
Population: All participants with valid measurements at both baseline and 12-months are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Child Behavior Checklist (CBCL) Summary Scale T Scores | -1.44 change in score on a scale | Standard Deviation 7.54 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Child Behavior Checklist (CBCL) Summary Scale T Scores | -4.55 change in score on a scale | Standard Deviation 9 |
Secondary
Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores.
Mean of blood pressures measured in triplicate (to 1.0 mmHg) via automated oscillometric blood pressure cuff. Percentiles calculated respective to height, age and sex (PMID: 18230679).
Time frame: 12 months
Population: All participants with 3 valid measurements at both baseline and 12-months are included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores. | Systolic | 4.75 Change in percentile | Standard Deviation 31.4 |
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores. | Diastolic | 2.20 Change in percentile | Standard Deviation 20.79 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores. | Systolic | -4.5 Change in percentile | Standard Deviation 28.9 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Mean Systolic and Diastolic Blood Pressures (mmHg) Percentile Scores. | Diastolic | -4.87 Change in percentile | Standard Deviation 22.52 |
Secondary
Change From Baseline to 12 Months in NIH-Toolbox 9-Hole Pegboard Dexterity Test Time
Fine motor coordination assessed by the time (in seconds) it takes a child to complete the NIH-Toolbox 9-Hole Pegboard Dexterity Test. Shorter times indicate greater dexterity. The reported value is the average of the dominant and non-dominant hand scores.
Time frame: 12 months
Population: All participants with valid measurements at both baseline and 12-months are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in NIH-Toolbox 9-Hole Pegboard Dexterity Test Time | -5.9 change in seconds | Standard Deviation 8 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in NIH-Toolbox 9-Hole Pegboard Dexterity Test Time | -5.3 change in seconds | Standard Deviation 7.4 |
Secondary
Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales.
General quality of life assessed by caregiver reported PedsQL total score and subscores (Psychosocial Health Summary Score & Physical Health Summary Score). The PedsQL Total Score comprises performance on 4 subscales: emotional functioning, social functioning, school functioning (summarized by the Psychosocial Functioning Score) and physical functioning (summarized by the Physical Functioning score). Scores on all scales range from 0 to 100, with higher scores indicating an increased quality of life.
Time frame: 12 months
Population: All participants with valid measurements at both baseline and 12-months are included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. | Parent - Psychosocial | -1.08 change in score on a scale | Standard Deviation 13.33 |
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. | Parent - Total | -2.62 change in score on a scale | Standard Deviation 15.02 |
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. | Parent - Physical | -5.34 change in score on a scale | Standard Deviation 24.32 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. | Parent - Total | 2.09 change in score on a scale | Standard Deviation 14.95 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. | Parent - Physical | 0.74 change in score on a scale | Standard Deviation 23.55 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Pediatric Quality of Life Inventory (PedsQL) Caregiver Reported Total Score and Subscales. | Parent - Psychosocial | 2.85 change in score on a scale | Standard Deviation 14.17 |
Secondary
Change From Baseline to 12 Months in Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorder Scale (PSQ-SRBD) Total Score.
The PSQ-SRBD scale is a 22-item questionnaire which includes three subscales: snoring, daytime sleepiness, and hyperactive behaviors/inattention. The PSQ-SRBD is commonly used to assess sleep-disordered breathing (SDB) risk in pediatric patients, but is also increasingly used to assess symptom burden. Higher scores correspond to greater SDB symptoms and the total range is 0-1
Time frame: 12 months
Population: All participants with valid measurements at both baseline and 12-months are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorder Scale (PSQ-SRBD) Total Score. | -0.07 change in score on a scale | Standard Deviation 0.16 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Pediatric Sleep Questionnaire: Sleep-Related Breathing Disorder Scale (PSQ-SRBD) Total Score. | -0.23 change in score on a scale | Standard Deviation 0.19 |
Secondary
Change From Baseline to 12 Months in Quality of Life Survey Evaluation of Sleep-Disordered Breathing (OSA-18) Total Score.
The OSA-18 is a disease-specific QOL survey that captures symptoms across five domains: sleep disturbance, physical suffering, emotional distress, daytime problems, and parent/caretaker concerns. With a Likert 7-point scale, caregivers rate the perceived frequency of 18 OSA-related problems ranging from 1 (none of the time) to 7 (all the time). Scores on each item are summed to produce a total score ranging from 18 to 126. Higher scores correspond to poorer sleep disordered breathing-related QOL, with a score greater than or equal to 60 signifying a clinically meaningful negative impact of sleep disordered breathing on QOL
Time frame: 12 months
Population: All participants with valid measurements at both baseline and 12-months are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Quality of Life Survey Evaluation of Sleep-Disordered Breathing (OSA-18) Total Score. | -6.03 change in score on a scale | Standard Deviation 14.59 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Quality of Life Survey Evaluation of Sleep-Disordered Breathing (OSA-18) Total Score. | -15.77 change in score on a scale | Standard Deviation 14.42 |
Secondary
Change From Baseline to 12 Months in Sleepiness Measured by Change in the Epworth Sleepiness Scale (ESS) Modified for Children Summary Score.
The Epworth Sleepiness Scale (ESS) Modified for Children is an 8-item validated questionnaire which evaluates excessive daytime sleepiness. The wording and questions are revised from the original ESS to be more suitable for children. The total score has a range from 0-24 where higher values indicate greater sleepiness.
Time frame: 12 months
Population: All participants with valid measurements at both baseline and 12-months are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Watchful Waiting With Supportive Care | Change From Baseline to 12 Months in Sleepiness Measured by Change in the Epworth Sleepiness Scale (ESS) Modified for Children Summary Score. | -0.67 change in score on a scale | Standard Deviation 4.39 |
| Early Adenotonsillectomy | Change From Baseline to 12 Months in Sleepiness Measured by Change in the Epworth Sleepiness Scale (ESS) Modified for Children Summary Score. | -1.77 change in score on a scale | Standard Deviation 4.95 |