Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children

Browse trials for

• Sleep Apnea, Obstructive 2,240
• Sleep Apnea Syndromes 1,084
• Child Behavior Disorders 35
• Attention Deficit Disorder with Hyperactivity 1,817
• Disorders of Excessive Somnolence 195
• Sleepiness 92

Keywords

• polysomnography
• child
• continuous positive airway pressure
• tonsillectomy
• neuropsychological tests
• cognition
• sleepiness
• behavior

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's enrollment of 120 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Study arms

• 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

• 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

Interventions

• ProcedureCPAP treatment

  6 months of treatment with PAP (CPAP or BPAP)

  Also known as: Continuous positive airway pressure device (CPAP), Bi-level positive airway pressure device (BPAP), Positive Airway Pressure device (PAP)

• OtherNo CPAP treatment

  Children randomized to the comparison group will receive routine care

  Also known as: Comparison group, Control group

Primary outcomes

1. 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.

   Time frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Secondary outcomes

1. 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

   Time frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

2. Change in Sleepiness as Measured by Epworth Sleepiness Scale

   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

3. 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.

   Time frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

4. 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

   Time frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

5. 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.

   Time frame: Starting at 4 months after AT and continuing through 10 months after AT

Other outcomes

1. 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

   Time frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

2. 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

   Time frame: assessed as change from baseline to 6 months of CPAP therapy or no-CPAP

Baseline characteristics

6 further baseline measures are reported on the registry.

Study documents

• Protocol and statistical analysis plan ↗ · Oct 16, 2018

PDFs hosted by the registry, ClinicalTrials.gov.