Steroids for Pediatric Apnea Research in Kids

Phase 3

Completed

Conditions: Obstructive Sleep Apnea Syndrome

Interventions: Drug: Nasal Fluticasone
Drug: Placebo

Registration Number: NCT02180672

Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 211

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal steroids	Nasal Fluticasone	Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).
Placebo	Placebo	Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).

Primary Outcome Measures

Name	Time	Method
Obstructive Apnea Hypopnea Index	3 months	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.

Secondary Outcome Measures

Name	Time	Method
The Epworth Sleepiness Scale	12 months	Epworth Sleepiness scale is a measure of sleepiness that ranges from 0-24, with higher values indicating sleepiness
Pediatric Quality of Life Inventory (PedsQL)	12 month	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
Behavior Rating Inventory of Executive Function (BRIEF)	12 months	Behavior Rating Inventory of Executive Function \[BRIEF\] Global Executive Composite T score, comprising summary measures of behavioral regulation and metacognition \[with mean scores of 50 and standard deviation of 10, with higher scores indicating worse functioning\]
Conners Abbreviated Symptom Questionnaire	12 months	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).
Purdue Peg Board	12 months	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.
OAHI	12 months	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.
Nasal Obstruction Symptom Evaluation (NOSE)	12 months	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
Conners Continuous Performance Test (CPT)	12 months	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)
Child Behavior Checklist	12-Months	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).