Sleep Apnea, Obstructive Clinical Trial
Official title:
Sleep-Disordered Breathing and CPAP After Adenotonsillectomy in Children
Verified date | January 2019 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Health System | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Michigan Technological University, National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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 |
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