Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01554527
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), Michigan Technological University (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 67.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Obstructive sleep-disordered breathing (SDB) affects 2-3% of children and may lead to problems with nighttime sleep and daytime behavior, learning, sleepiness, and mood. Adenotonsillectomy (AT) is the second most common surgical procedure in children. It is now performed more often for suspected SDB than for any other indication. However, recent studies indicate that many if not most children still have SDB after AT, and many still have learning or behavioral problems associated with SDB. The goals of this study are: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with Continuous positive airway pressure (CPAP) treatment after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Child Behavior Disorders; Attention Deficit Disorder With Hyperactivity; Disorders of Excessive Somnolence	Procedure: CPAP treatment; Other: No CPAP treatment	N/A

Detailed Description

Obstructive sleep-disordered breathing (SDB) affects at least 2-3% of children and may have substantial adverse impact on behavior and cognition. Adenotonsillectomy (AT), the second most common surgical procedure in children, is now performed more often for suspected SDB than for any other indication. However, recent studies among an increasingly obese population now show something alarming: many if not most children still have SDB after AT, and many still suffer from residual neurobehavioral morbidity. Furthermore, the investigators' ongoing, 12-year, NIH-funded research has shown that standard preoperative polysomnographic measures of SDB do not consistently predict post-AT improvement in behavior and cognition. This may arise in part because many children after AT still have SDB, and because linear relationships between standard SDB measures and neurobehavioral morbidity may not exist. Even at subtle levels, SDB may promote significant neurobehavioral morbidity. Some have suggested that polysomnography may be more important after AT than before AT. However, in practice few children receive polysomnography before AT, and even fewer after AT, when continuous positive airway pressure (CPAP) could still provide definitive relief from SDB. Preliminary data from our group suggest that CPAP after AT is well-tolerated by most children and may provide significant benefit. However, virtually no published evidence exists to address critical clinical questions: which children benefit most from CPAP after AT; what role can clinical symptoms or polysomnography play in that determination; and what neurobehavioral gains are achieved by CPAP after AT?

The investigators therefore will undertake a highly practical, clinical study with two main goals: (1) to assess the extent that behavior, cognition, and sleepiness in children can improve with CPAP after AT, and (2) to identify which patients stand to gain most from post-operative assessment and treatment. This research will use reversible SDB-related neurobehavioral morbidity as the criteria by which to judge the utility of clinical symptoms and polysomnography in identification of candidates for CPAP after AT.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Oct 29, 2017
• Actual Study Completion Date: Oct 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPAP treatment Children randomized to this arm will receive 6 months of CPAP (or BPAP) treatment, beginning at approximately 4 months after AT, in addition to standard of care. For analysis purposes those children who were non-adherent (CPAP use <4 hours per night) vs. adherent (CPAP use at least 4 hours per night) will be analyzed separately.	Procedure: CPAP treatment; 6 months of treatment with PAP (CPAP or BPAP); Other Names: Continuous positive airway pressure device (CPAP) Bi-level positive airway pressure device (BPAP) Positive Airway Pressure device (PAP)
Other: No CPAP treatment Children randomized to this comparison arm will not be treated with CPAP or BPAP, but will be followed for approximately 10 months after AT while receiving standard of care.	Other: No CPAP treatment; Children randomized to the comparison group will receive routine care; Other Names: Comparison group Control group

Outcome Measures

Primary Outcome Measures

1. Change in Behavioral Index After 6 Months of CPAP or No-CPAP [assessed as change from baseline to 6 months of CPAP therapy or no-CPAP]

   The sum of the T-scores of The Conners' Parent Rating Scales (CPRS-R:L, ADHD index) and the Child Behavior Checklist (CBCL, Attention Deficit/Hyperactivity Problems) are used to construct the primary study outcome measure Behavioral Index. Behavioral index is a T score (adjusted for age and gender) with a range of "<10" to ">90" - where higher scores mean worse behavior and lower scores mean better behavior, so a negative change score represents an improvement in behavior. T-scores with a mean of 50 and SD of 10 are computed.

Secondary Outcome Measures

1. Change in Cognition as Shown by NIH Toolbox Composite Score [assessed as change from baseline to 6 months of CPAP therapy or no-CPAP]

   Scores are reported as standardized scores with a mean of 100 and SD of 15. Minimum value 40 and Maximum value 160. Higher scores are better

2. Change in Sleepiness as Measured by Epworth Sleepiness Scale [assessed as change from baseline to 6 months of CPAP therapy or no-CPAP]

   Epworth Sleepiness Scale scores range from 0 to 24 where higher scores mean greater sleepiness.

3. Change in Sleepiness After AT as Measured by Multiple Sleep Latency Test (MSLT) [assessed as change from baseline to 6 months of CPAP therapy or no-CPAP]

   Multiple Sleep Latency Test (MSLT) is an objective measure of sleepiness determined by measure of brain waves and other physiological signals over a 30 minute period. This is measured for five 30 minute periods across the day and average latency to sleep for each participant across those times were used to calculate the mean sleep latency. The score is measured in how quickly one would fall asleep, measured in minutes, so a negative number of minutes in the change score means that participants fell asleep more quickly than previously.

4. Change in Quality of Life as Measured by Peds QL [assessed as change from baseline to 6 months of CPAP therapy or no-CPAP]

   Peds-QL is a quality of life symptom measurement with a score range of 0 to 100. Higher scores are better quality of life

5. CPAP Adherence as Measured by Number of Participants Who Used the CPAP Consistently. [Starting at 4 months after AT and continuing through 10 months after AT]

   CPAP adherence data will be downloaded from CPAP machines. It is defined for this study as using the CPAP machine for at least an average of 4 hours per night during the last 60 days of the assignment.

Other Outcome Measures

1. Change in Cognition as Measured by Fluid Cognition Scores [assessed as change from baseline to 6 months of CPAP therapy or no-CPAP]

   Scores are reported as standardized scores with a mean of 100 and SD of 15. Minimum value 40, Maximum value 160. Higher scores are better

2. Change in Cognition After AT as Shown by Academic Achievement [assessed as change from baseline to 6 months of CPAP therapy or no-CPAP]

   Academic achievement mean score is a standardized score with a mean of 100 and SD 15. Minimum value 40 and Maximum value 160. Higher scores are better

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Children ages 5-12 years old,

2. Scheduled for an adenotonsillectomy for treatment of sleep apnea,

3. Child must provide assent, and

4. Parent or legal guardian must be able to speak and read English, and agree to the study.

Exclusion Criteria:

1. No siblings of children already enrolled in the study,

2. Children who expect to have another surgery (in addition to AT) during the period of participation in this study,

3. Neurological, psychiatric, or medical conditions, or social factors that may affect test results, prevent children from returning for required study visits, or interfere with the study treatment, or

4. Certain medications that affect sleepiness or alertness, for example:

• Stimulants (such as Ritalin, Adderall, or Concerta),

• Sleep aides (such as Melatonin, Ambien, or Ativan), or

• Sedating medicines (such as Benadryl, Klonopin, Xanax, or Valerian).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Health System	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• National Heart, Lung, and Blood Institute (NHLBI)
• Michigan Technological University

Investigators

• Principal Investigator: Ronald D. Chervin, MD, MS, University of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2018

More Information

Publications

None provided.

• Responsible Party: Ronald D. Chervin, M.D., M.S., Professor of Neurology, University of Michigan
• ClinicalTrials.gov Identifier: NCT01554527
• Other Study ID Numbers: F029661-00; 1R01HL105999-01A1
• First Posted: Mar 15, 2012
• Last Update Posted: Jan 14, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Ronald D. Chervin, M.D., M.S., Professor of Neurology, University of Michigan: polysomnography; child; continuous positive airway pressure; tonsillectomy; neuropsychological tests; cognition; sleepiness; behavior
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Disorders of Excessive Somnolence; Disease; Sleepiness; Attention Deficit Disorder with Hyperactivity; Mental Disorders; Child Behavior Disorders

Study Results

Participant Flow

Recruitment Details	Of 120 consented, 105 were randomized to CPAP or control. (Of the 15 who weren't randomized, 8 were lost to follow up; the other withdrew for various reasons)

Arm/Group Title	Control Group (Surgery Only - no CPAP)	CPAP After Surgery (Adherent)	CPAP After Surgery (Non-adherent)
Arm/Group Description	The participants who were not assigned to CPAP	Those participants assigned to CPAP who had at least 4 hours of electronically recorded CPAP use per night	Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night.
Period Title: Overall Study
STARTED	34	38	33
Crossed Over to Control	0	0	2
Had CPAP Titration	0	38	30
Initiated CPAP Treatment at Home	0	38	28
Completed as a Control	33	0	1
COMPLETED	33	38	25
NOT COMPLETED	1	0	8

Baseline Characteristics

Arm/Group Title	Control Group (Surgery Only - no CPAP)	CPAP After Surgery (Adherent)	CPAP After Surgery (Non-adherent)	Total
Arm/Group Description	The participants who were not assigned to CPAP	Those participants assigned to CPAP who had at least 4 hours of electronically recorded CPAP use per night	Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night.	Total of all reporting groups
Overall Participants	34	38	33	105
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.9 (2.0)	8.3 (2.2)	8.0 (2.0)	8.1 (2.1)
Sex: Female, Male (Count of Participants)
Female	13 38.2%	21 55.3%	16 48.5%	50 47.6%
Male	21 61.8%	17 44.7%	17 51.5%	55 52.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 14.7%	2 5.3%	0 0%	7 6.7%
Not Hispanic or Latino	29 85.3%	36 94.7%	33 100%	98 93.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 2.9%	1 2.6%	1 3%	3 2.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 2.9%	5 13.2%	8 24.2%	14 13.3%
White	28 82.4%	29 76.3%	19 57.6%	76 72.4%
More than one race	4 11.8%	3 7.9%	5 15.2%	12 11.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	34 100%	38 100%	33 100%	105 100%
Behavioral Index (units on a scale (T-Score)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale (T-Score)]	61.6 (13.4)	56.5 (11.3)	57.8 (11.6)	58.5 (12.1)
NIH Toolbox Age adjusted composite score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	95.7 (11.9)	96.2 (12.3)	93.9 (11.6)	95.1 (11.6)
Epworth Sleepiness Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.2 (4.6)	6.9 (3.9)	6.4 (3.0)	6.8 (3.9)
Multiple Sleep Latency Test (MSLT) (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	24.7 (6.0)	25.9 (4.6)	24.4 (5.4)	25.0 (5.3)
Quality of Life (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	78.2 (13.7)	78.7 (16)	77.3 (17.2)	78.1 (14.9)
Academic Achievement Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	104.1 (13.4)	107.2 (14.6)	102.1 (10.7)	104.6 (13.1)
Fluid Cognition Composite Age Adjusted score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	97.3 (13.2)	96 (14.2)	93.9 (11.6)	95.8 (13.1)
(Apnea-Hypopnea Index (AHI) (events/hour) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [events/hour]	2.4 (2.0)	2.2 (1.7)	2.1 (2.0)	2.2 (1.9)
Sleep Related Breathing Disturbances (SBRD) sub-scale of Pediatric Sleep Questionnaire (Ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Ratio]	0.36 (0.24)	0.32 (0.21)	0.37 (0.17)	0.35 (0.21)

Outcome Measures

1. Primary Outcome

Title	Change in Behavioral Index After 6 Months of CPAP or No-CPAP
Description	The sum of the T-scores of The Conners' Parent Rating Scales (CPRS-R:L, ADHD index) and the Child Behavior Checklist (CBCL, Attention Deficit/Hyperactivity Problems) are used to construct the primary study outcome measure Behavioral Index. Behavioral index is a T score (adjusted for age and gender) with a range of "<10" to ">90" - where higher scores mean worse behavior and lower scores mean better behavior, so a negative change score represents an improvement in behavior. T-scores with a mean of 50 and SD of 10 are computed.
Time Frame	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Outcome Measure Data

Analysis Population Description

Data for two participants in the control group are not available.

Arm/Group Title	Control Group (Surgery Only - no CPAP)	CPAP After Surgery (Non-adherent)	CPAP After Surgery (Adherent)
Arm/Group Description	The participants who were not assigned to CPAP	Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period	Those participants assigned to CPAP who had an average of at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period
Measure Participants	32	25	38
Mean (Standard Deviation) [T score]	-2.7 (5.8)	.9 (4.8)	-1.2 (6.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group (Surgery Only - no CPAP), CPAP After Surgery (Non-adherent), CPAP After Surgery (Adherent)
	Comments	Intent to treat for controls vs. treatment (adherent/non-adherent)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Change in Cognition as Shown by NIH Toolbox Composite Score
Description	Scores are reported as standardized scores with a mean of 100 and SD of 15. Minimum value 40 and Maximum value 160. Higher scores are better
Time Frame	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Outcome Measure Data

Analysis Population Description

Lower numbers of participants analyzed are shown here because the tool is not appropriate for younger children

Arm/Group Title	Control Group (Surgery Only - no CPAP)	CPAP After Surgery (Non-adherent)	CPAP After Surgery (Adherent)
Arm/Group Description	The participants who were not assigned to CPAP	Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period	Those participants assigned to CPAP who had an average of at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period
Measure Participants	27	23	38
Mean (Standard Deviation) [score on a scale]	5.5 (9.5)	2.8 (9.8)	3.9 (7.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group (Surgery Only - no CPAP), CPAP After Surgery (Non-adherent), CPAP After Surgery (Adherent)
	Comments	Intent to treat for controls vs. treatment (adherent/non-adherent)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Change in Sleepiness as Measured by Epworth Sleepiness Scale
Description	Epworth Sleepiness Scale scores range from 0 to 24 where higher scores mean greater sleepiness.
Time Frame	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Outcome Measure Data

Analysis Population Description

Data for two participants are not available

Arm/Group Title	Control Group (Surgery Only - no CPAP)	CPAP After Surgery (Non-adherent)	CPAP After Surgery (Adherent)
Arm/Group Description	The participants who were not assigned to CPAP	Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period	Those participants assigned to CPAP who had an average of at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period
Measure Participants	33	25	37
Mean (Standard Deviation) [score on a scale]	-1.6 (3.7)	-1.0 (2.2)	-1.9 (3.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group (Surgery Only - no CPAP), CPAP After Surgery (Non-adherent), CPAP After Surgery (Adherent)
	Comments	Intent to treat for controls vs. treatment (adherent/non-adherent)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Change in Sleepiness After AT as Measured by Multiple Sleep Latency Test (MSLT)
Description	Multiple Sleep Latency Test (MSLT) is an objective measure of sleepiness determined by measure of brain waves and other physiological signals over a 30 minute period. This is measured for five 30 minute periods across the day and average latency to sleep for each participant across those times were used to calculate the mean sleep latency. The score is measured in how quickly one would fall asleep, measured in minutes, so a negative number of minutes in the change score means that participants fell asleep more quickly than previously.
Time Frame	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Outcome Measure Data

Analysis Population Description

Data for one participant are not available

Arm/Group Title	Control Group (Surgery Only - no CPAP)	CPAP After Surgery (Non-adherent)	CPAP After Surgery (Adherent)
Arm/Group Description	The participants who were not assigned to CPAP	Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period	Those participants assigned to CPAP who had an average of at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period
Measure Participants	33	25	38
Mean (Standard Deviation) [minutes]	-1.8 (4)	-1.3 (5.1)	-1.1 (4.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group (Surgery Only - no CPAP), CPAP After Surgery (Non-adherent), CPAP After Surgery (Adherent)
	Comments	Intent to treat for controls vs. treatment (adherent/non-adherent)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Change in Quality of Life as Measured by Peds QL
Description	Peds-QL is a quality of life symptom measurement with a score range of 0 to 100. Higher scores are better quality of life
Time Frame	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Outcome Measure Data

Analysis Population Description

Data for one participant is not available

Arm/Group Title	Control Group (Surgery Only - no CPAP)	CPAP After Surgery (Non-adherent)	CPAP After Surgery (Adherent)
Arm/Group Description	The participants who were not assigned to CPAP	Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period	Those participants assigned to CPAP who had an average of at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period
Measure Participants	33	25	38
Mean (Standard Deviation) [score on a scale]	4.1 (9.0)	0.5 (10.2)	2.4 (12.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group (Surgery Only - no CPAP), CPAP After Surgery (Non-adherent), CPAP After Surgery (Adherent)
	Comments	Intent to treat for controls vs. treatment (adherent/non-adherent)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	CPAP Adherence as Measured by Number of Participants Who Used the CPAP Consistently.
Description	CPAP adherence data will be downloaded from CPAP machines. It is defined for this study as using the CPAP machine for at least an average of 4 hours per night during the last 60 days of the assignment.
Time Frame	Starting at 4 months after AT and continuing through 10 months after AT

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CPAP Group
Arm/Group Description	Participants who were assigned to CPAP use.
Measure Participants	71
Count of Participants [Participants]	38 111.8%

7. Other Pre-specified Outcome

Title	Change in Cognition as Measured by Fluid Cognition Scores
Description	Scores are reported as standardized scores with a mean of 100 and SD of 15. Minimum value 40, Maximum value 160. Higher scores are better
Time Frame	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Outcome Measure Data

Analysis Population Description

Lower numbers are shown here as the tool is not appropriate for younger children

Arm/Group Title	Control Group (Surgery Only - no CPAP)	CPAP After Surgery (Non-adherent)	CPAP After Surgery (Adherent)
Arm/Group Description	The participants who were not assigned to CPAP	Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period	Those participants assigned to CPAP who had an average of at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period
Measure Participants	29	23	38
Mean (Standard Deviation) [score on a scale]	6.7 (12.4)	1.7 (11.5)	3.4 (10.1)

8. Other Pre-specified Outcome

Title	Change in Cognition After AT as Shown by Academic Achievement
Description	Academic achievement mean score is a standardized score with a mean of 100 and SD 15. Minimum value 40 and Maximum value 160. Higher scores are better
Time Frame	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Outcome Measure Data

Analysis Population Description

Data from two participants are not available

Arm/Group Title	Control Group (Surgery Only - no CPAP)	CPAP After Surgery (Non-adherent)	CPAP After Surgery (Adherent)
Arm/Group Description	The participants who were not assigned to CPAP	Those participants assigned CPAP who did not have at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period	Those participants assigned to CPAP who had an average of at least 4 hours of electronically recorded CPAP use per night over the last 60 days of the 6 month usage period
Measure Participants	32	25	37
Mean (Standard Deviation) [units on a scale]	-1.0 (5.6)	1.1 (4.7)	-2.5 (8.6)

Adverse Events

Time Frame	Adverse events were followed from consent (which could be before surgery or after surgery) until 10 months after surgery equating to six months after assignment.
Adverse Event Reporting Description	Based on the adverse event collection structure, it bears noting that some reported AEs may have happened prior to assignment to CPAP or no CPAP use, to participants who ended up reaching baseline visit (4 months after surgery). Since both adherent and non-adherent CPAP participants received CPAP with minimum 1 night of CPAP, these 2 groups were combined for the purposes of AE reporting in order to determine whether any CPAP exposure vs control group (no CPAP) had a different proportion of AE's.
Arm/Group Title	CPAP Treatment Group on CPAP		No CPAP Treatment Group		Non-randomized Participants
Arm/Group Description	Children randomized to this arm were assigned and began up to 6 months of CPAP treatment, beginning at approximately 4 months after AT, in addition to standard of care. This arm shows AEs that happened to participants randomized to CPAP but who didn't cross over to the No CPAP group prior to sleep lab. (n=69; original n=71 minus n=2 who crossed over to no-CPAP group). Since both adherent and non-adherent CPAP participants received CPAP and had at minimum one night of CPAP exposure, these two groups were combined for the purposes of AE reporting in order to determine whether any CPAP exposure vs control group (no CPAP) had a different proportion of AE's.		Children shown in this comparison arm were randomized to NO CPAP or were crossed over to No CPAP prior to any CPAP use or CPAP trial in sleep lab.) (N = 36, original 34 plus two crossed over from those randomized to CPAP)		Participants who were consented but withdrew prior to randomization (n = 15)
All Cause Mortality
	CPAP Treatment Group on CPAP		No CPAP Treatment Group		Non-randomized Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/69 (0%)		0/36 (0%)		0/15 (0%)
Serious Adverse Events
	CPAP Treatment Group on CPAP		No CPAP Treatment Group		Non-randomized Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/69 (8.7%)		7/36 (19.4%)		4/15 (26.7%)
Psychiatric disorders
ER admission due to panic attack	1/69 (1.4%)		0/36 (0%)		0/15 (0%)
Respiratory, thoracic and mediastinal disorders
Hospitalization for ashthma	1/69 (1.4%)		0/36 (0%)		0/15 (0%)
Surgical and medical procedures
Post-operative hospitalization	4/69 (5.8%)		7/36 (19.4%)		4/15 (26.7%)
Other (Not Including Serious) Adverse Events
	CPAP Treatment Group on CPAP		No CPAP Treatment Group		Non-randomized Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/69 (85.5%)		26/36 (72.2%)		7/15 (46.7%)
Ear and labyrinth disorders
Ear Pain	2/69 (2.9%)		0/36 (0%)		2/15 (13.3%)
Eye disorders
Pink Eye	2/69 (2.9%)		2/36 (5.6%)		0/15 (0%)
Gastrointestinal disorders
Constipation	4/69 (5.8%)		0/36 (0%)		0/15 (0%)
GI Distress	7/69 (10.1%)		1/36 (2.8%)		1/15 (6.7%)
Stomach Flu	14/69 (20.3%)		5/36 (13.9%)		0/15 (0%)
Vomiting	7/69 (10.1%)		2/36 (5.6%)		0/15 (0%)
General disorders
Cold Symptoms	38/69 (55.1%)		16/36 (44.4%)		2/15 (13.3%)
Flu-like Symptoms	0/69 (0%)		3/36 (8.3%)		0/15 (0%)
Immune system disorders
Allergic Reaction	8/69 (11.6%)		5/36 (13.9%)		0/15 (0%)
Infections and infestations
HFMD	0/69 (0%)		2/36 (5.6%)		0/15 (0%)
Strep Throat	1/69 (1.4%)		1/36 (2.8%)		1/15 (6.7%)
Upper Respiratory Infection	7/69 (10.1%)		6/36 (16.7%)		2/15 (13.3%)
Injury, poisoning and procedural complications
Unrelated Accident	22/69 (31.9%)		9/36 (25%)		1/15 (6.7%)
Nervous system disorders
Headache	3/69 (4.3%)		2/36 (5.6%)		0/15 (0%)
Psychiatric disorders
Anxiety	12/69 (17.4%)		8/36 (22.2%)		0/15 (0%)
Renal and urinary disorders
Enuresis	5/69 (7.2%)		0/36 (0%)		0/15 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation	17/69 (24.6%)		5/36 (13.9%)		0/15 (0%)
Voice Alteration	1/69 (1.4%)		3/36 (8.3%)		0/15 (0%)
Skin and subcutaneous tissue disorders
Molluscum Contagiosum	0/69 (0%)		2/36 (5.6%)		0/15 (0%)
Skin Irritation	42/69 (60.9%)		12/36 (33.3%)		0/15 (0%)
Social circumstances
Behavior Issues	11/69 (15.9%)		4/36 (11.1%)		0/15 (0%)
Life Event or Change	2/69 (2.9%)		5/36 (13.9%)		1/15 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.