N/A
N=105
Continuous Positive Airway Pressure (CPAP) After Adenotonsillectomy in Children
Sleep Apnea, Obstructive · Sleep Apnea Syndromes · Child Behavior Disorders · Attention Deficit Disorder With Hyperactivity · Disorders of Excessive Somnolence
Bottom Line
View on ClinicalTrials.gov: NCT01554527 ↗Enrolled (actual)
105
Serious AEs
14.2%
Results posted
Jan 2019
Primary outcome: Primary: Change in Behavioral Index After 6 Months of CPAP or No-CPAP — -2.7; .9; -1.2 T score — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP treatment (Procedure); No CPAP treatment (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Behavioral Index After 6 Months of CPAP or No-CPAP |
-2.7; .9; -1.2 | 0.07 |
| SECONDARY Change in Cognition as Shown by NIH Toolbox Composite Score |
5.5; 2.8; 3.9 | 0.34 |
| SECONDARY Change in Sleepiness as Measured by Epworth Sleepiness Scale |
-1.6; -1.0; -1.9 | 0.93 |
| SECONDARY Change in Sleepiness After AT as Measured by Multiple Sleep Latency Test (MSLT) |
-1.8; -1.3; -1.1 | 0.5 |
| SECONDARY Change in Quality of Life as Measured by Peds QL |
4.1; 0.5; 2.4 | 0.25 |
| SECONDARY CPAP Adherence as Measured by Number of Participants Who Used the CPAP Consistently. |
38 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Children ages 5-12 years old,
- Scheduled for an adenotonsillectomy for treatment of sleep apnea,
- Child must provide assent, and
- Parent or legal guardian must be able to speak and read English, and agree to the study.
Exclusion Criteria
- No siblings of children already enrolled in the study,
- Children who expect to have another surgery (in addition to AT) during the period of participation in this study,
- 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
- 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).
Data sourced from ClinicalTrials.gov (NCT01554527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.