Trial record 1 of 1 for:    NCT02180672
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Steroids for Pediatric Apnea Research in Kids (SPARK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia Identifier:
First received: July 1, 2014
Last updated: October 5, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Obstructive Sleep Apnea Syndrome
Drug: Nasal Fluticasone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea

Resource links provided by NLM:

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Apnea hypopnea index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Efficacy measure to assess acute response to nasal steroids.

Secondary Outcome Measures:
  • AHI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Efficacy measure to assess duration of response to nasal steroids.

  • Nasal Obstruction Symptom Evaluation (NOSE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The Epworth Sleepiness Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The Child Behavior Checklist (CBCL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Conners Abbreviated Symptom Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Conners Kiddie Continuous Performance Test, Version 5 (K-CPT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Purdue Peg Board [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Knee height [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • DXA-measured bone density [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • cortisol level [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Ophthalmologic exam [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 318
Study Start Date: September 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nasal steroids
Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone).
Drug: Nasal Fluticasone
One spray per nostril, per day.
Other Names:
  • NCS
  • Nasal steroids
  • Nasal corticosteroids
Placebo Comparator: Placebo
Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline).
Drug: Placebo
One spray per nostril, per day.
Other Name: Saline

Detailed Description:
Several studies have suggested that 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.

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 SpO2 <90%, end-tidal 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., 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 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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02180672

Contact: Ruth Bradford 2674265747
Contact: Mary Anne Cornaglia 2674265748

United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ruth Bradford    267-426-6567   
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Carole L Marcus, MBBCh Children's Hospital of Philadelphia
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Hospital of Philadelphia Identifier: NCT02180672     History of Changes
Other Study ID Numbers: 14-010942, R01HL120909
Study First Received: July 1, 2014
Last Updated: October 5, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Obstructive sleep apnea syndrome
sleep apnea
nasal steroids

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on November 24, 2015