Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

Sleep Apnea, Obstructive Clinical Trial

Official title:

Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554527
• Other study ID #: F029661-00
• Secondary ID: 1R01HL105999-01A
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: October 29, 2017

Study information

• Verified date: January 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 29, 2017
• Est. primary completion date: October 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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).

Related Conditions & MeSH terms

• Apnea
• Attention Deficit Disorder with Hyperactivity
• Child Behavior Disorders
• Disease
• Disorders of Excessive Somnolence
• Mental Disorders
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• CPAP treatment
6 months of treatment with PAP (CPAP or BPAP)

Other:
• No CPAP treatment
Children randomized to the comparison group will receive routine care

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Michigan Technological University, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Cognition as Measured by Fluid Cognition Scores	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	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Other	Change in Cognition After AT as Shown by Academic Achievement	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	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Primary	Change in Behavioral Index After 6 Months of CPAP 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.	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Secondary	Change in Cognition as Shown by NIH Toolbox Composite Score	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	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Secondary	Change in Sleepiness as Measured by Epworth Sleepiness Scale	Epworth Sleepiness Scale scores range from 0 to 24 where higher scores mean greater sleepiness.	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Secondary	Change in Sleepiness After AT as Measured by Multiple Sleep Latency Test (MSLT)	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.	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Secondary	Change in Quality of Life as Measured by Peds QL	Peds-QL is a quality of life symptom measurement with a score range of 0 to 100. Higher scores are better quality of life	assessed as change from baseline to 6 months of CPAP therapy or no-CPAP
Secondary	CPAP Adherence as Measured by Number of Participants Who Used the CPAP Consistently.	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.	Starting at 4 months after AT and continuing through 10 months after AT