- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180672
Steroids for Pediatric Apnea Research in Kids (SPARK)
Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- 5-10 years of age.
- Mild to moderate OSAS, defined as an obstructive apnea index of 1-20/hr of total sleep time or obstructive apnea hypopnea index of 2-30/hr of total sleep time.
- Parent-related symptoms of habitual snoring (>3 nights per week)
- No history of adenotonsillectomy.
- Parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion Criteria
- Severe OSAS or significant hypoxemia or hypercapnia on polysomnography, such that definitive treatment should not be delayed (AHI > 30/hr, more than 2% total sleep time with arterial oxygen saturation (SpO2) <90%, end-tidal carbon dioxide partial pressure (PCO2) > 60 mm Hg for > 5 minutes, pathologic arrhythmias).
- History of recurrent throat infections (as defined by the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines For Tonsillectomy (7)) in the past few years as follows: > 7 episodes in the past year or > 5 episodes/year over the past 2 years or > 3 episodes/year over the past 3 years.
- Abnormalities on baseline safety screening tests, i.e., Dual Energy X-ray Absorptiometry (DXA) scan showing spine or whole body bone mineral density < -2.0 standard deviations using race specific curves with adjustment for height Z-score; morning cortisol < 3 µg/dl or morning adrenocorticotropic hormone (ACTH) < 10 pg/ml; or ophthalmologic exam demonstrating cataracts (except those with < 2 mm anterior polar cataracts), aphakia or other ocular abnormalities such as glaucoma, retinal coloboma, intraocular inflammation or microphthalmia.
- Failure to thrive (weight/height < 5th percentile for age and gender), as this may be secondary to OSAS.
- Severe obesity (BMI z-score > 3) as OSAS is likely to persist in these subjects.
- Previous adenoidectomy unless adenoidal tissue has been documented to have regrown.
- Previous tonsillectomy.
- Continuous positive airway pressure (CPAP) therapy.
- Any NCS use in the past 3 months or NCS use for > 2 weeks in the past year.
- Current immunotherapy or daily antihistamine use.
- Recent (past month) nasal septum ulcers, surgery or trauma.
- Other major illness other than asthma, such as craniofacial anomalies, endocrine or neuromuscular disease, or past history of cancer. This includes children with conditions that may be worsened by OSAS, such as hypertension or diabetes.
- Current use of ketoconazole or other potent CYP3A4 inhibitors.
- Families planning to move out of the area within the year.
- Subjects who do not speak either English or Spanish well enough to complete the validated neurobehavioral instruments.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Nasal steroids
Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).
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One spray per nostril, per day.
Other Names:
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PLACEBO_COMPARATOR: Placebo
Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).
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One spray per nostril, per day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obstructive Apnea Hypopnea Index
Time Frame: 3 months
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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. |
3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OAHI
Time Frame: 12 months
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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. |
12 months
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Nasal Obstruction Symptom Evaluation (NOSE)
Time Frame: 12 months
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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
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12 months
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The Epworth Sleepiness Scale
Time Frame: 12 months
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Epworth Sleepiness scale is a measure of sleepiness that ranges from 0-24, with higher values indicating sleepiness
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12 months
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Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 12 month
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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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12 month
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Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame: 12 months
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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]
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12 months
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Conners Abbreviated Symptom Questionnaire
Time Frame: 12 months
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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).
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12 months
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Purdue Peg Board
Time Frame: 12 months
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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.
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12 months
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Conners Continuous Performance Test (CPT)
Time Frame: 12 months
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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)
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12 months
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Child Behavior Checklist
Time Frame: 12-Months
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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).
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12-Months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carole L Marcus, MBBCh, Children's Hospital of Philadelphia
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
Other Study ID Numbers
- 14-010942
- R01HL120909 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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