This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy, duration of action and side-effects will be determined.
Several studies have suggested that Nasal corticosteroids (NCS) or leukotriene antagonists may be effective in the treatment of childhood OSAS. However, these studies have been limited by factors such as small size, lack of randomization and blinding, short-term follow-up, involvement of children with only very mild OSAS, and/or lack of stratifying for the presence of atopy. Therefore, investigators will plan a randomized controlled trial evaluating the efficacy and safety of NCS vs placebo in children with mild to moderate OSAS. The overall hypothesis is that NCS will be safe and efficacious in the treatment of mild to moderate childhood OSAS, particularly in children with asthma/atopy, but will require ongoing maintenance therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
211
One spray per nostril, per day.
One spray per nostril, per day.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Obstructive Apnea Hypopnea Index
Efficacy measure to assess acute response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome.
Time frame: 3 months
OAHI
Efficacy measure to assess duration of response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points.
Time frame: 12 months
Nasal Obstruction Symptom Evaluation (NOSE)
Nasal Obstruction Symptom Evaluation (NOSE) scale, a validated scale of nasal obstructive symptoms. The scales ranges from 0-100 with higher values indicating worse nasal obstruction
Time frame: 12 months
The Epworth Sleepiness Scale
Epworth Sleepiness scale is a measure of sleepiness that ranges from 0-24, with higher values indicating sleepiness
Time frame: 12 months
Pediatric Quality of Life Inventory (PedsQL)
Pediatric Quality of Life Inventory (PedsQL), a well-validated, generic measure of global quality of life, in which scores range from 0 to 100, with higher scores indicating better quality of life
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Time frame: 12 month
Behavior Rating Inventory of Executive Function (BRIEF)
Behavior Rating Inventory of Executive Function \[BRIEF\] Global Executive Composite T score, comprising summary measures of behavioral regulation and metacognition \[with mean scores of 50 and standard deviation of 10, with higher scores indicating worse functioning\]
Time frame: 12 months
Conners Abbreviated Symptom Questionnaire
A parent-rated measure of symptoms of attention problems, yielding T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning).
Time frame: 12 months
Purdue Peg Board
The Purdue Peg Board is a widely used test of fine motor coordination, yields z-scores with a mean of 0 and a standard deviation of 1, with higher scores indicating better performance.
Time frame: 12 months
Conners Continuous Performance Test (CPT)
The CPT is a performance measure of sustained attention that yields T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning)
Time frame: 12 months
Child Behavior Checklist
The Child Behavior Checklist (CBCL), is a widely used and validated caregiver-completed survey of behavior competencies that yields standardized, age-adjusted scores on internalizing, externalizing and attentional behavior difficulties81, 82. All scores are T scores with a mean of 50 and standard deviation of 10 (higher scores indicate worse functioning).
Time frame: 12-Months