Steroids for Pediatric Apnea Research in Kids
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Nasal Fluticasone; Placebo
Intervention description: One spray per nostril, per day.; One spray per nostril, per day.
Intervention MeSH terms: Fluticasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 211.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Obstructive sleep apnea syndrome; OSA; sleep apnea; nasal steroids; corticosteroids

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.
    

Eligibility criteria:

        Inclusion Criteria

          1. 5-10 years of age.

          2. 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.

          3. Parent-related symptoms of habitual snoring (>3 nights per week)

          4. No history of adenotonsillectomy.

          5. Parental/guardian permission (informed consent) and if appropriate, child assent

        Exclusion Criteria

          1. 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).

          2. 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.

          3. 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.

          4. Failure to thrive (weight/height < 5th percentile for age and gender), as this may be
             secondary to OSAS.

          5. Severe obesity (BMI z-score > 3) as OSAS is likely to persist in these subjects.

          6. Previous adenoidectomy unless adenoidal tissue has been documented to have regrown.

          7. Previous tonsillectomy.

          8. Continuous positive airway pressure (CPAP) therapy.

          9. Any NCS use in the past 3 months or NCS use for > 2 weeks in the past year.

         10. Current immunotherapy or daily antihistamine use.

         11. Recent (past month) nasal septum ulcers, surgery or trauma.

         12. 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.

         13. Current use of ketoconazole or other potent CYP3A4 inhibitors.

         14. Families planning to move out of the area within the year.

         15. Subjects who do not speak either English or Spanish well enough to complete the
             validated neurobehavioral instruments.

         16. Parents/guardians or subjects who, in the opinion of the Investigator, may be
             non-compliant with study schedules or procedures.