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Steroids for Pediatric Apnea Research in Kids (SPARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02180672
Recruitment Status : Completed
First Posted : July 3, 2014
Last Update Posted : February 5, 2020
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Drug: Nasal Fluticasone Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea
Study Start Date : September 2014
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Fluticasone

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Apnea hypopnea index [ Time Frame: 3 months ]
    Efficacy measure to assess acute response to nasal steroids.

Secondary Outcome Measures :
  1. AHI [ Time Frame: 12 months ]
    Efficacy measure to assess duration of response to nasal steroids.

  2. Nasal Obstruction Symptom Evaluation (NOSE) [ Time Frame: 12 months ]
  3. The Epworth Sleepiness Scale [ Time Frame: 12 months ]
  4. The Child Behavior Checklist (CBCL) [ Time Frame: 12 months ]
  5. Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 12 month ]
  6. Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: 12 months ]
  7. Conners Abbreviated Symptom Questionnaire [ Time Frame: 12 months ]
  8. Conners Kiddie Continuous Performance Test, Version 5 (K-CPT) [ Time Frame: 12 months ]
  9. Purdue Peg Board [ Time Frame: 12 months ]
  10. Knee height [ Time Frame: 12 months ]
  11. DXA-measured bone density [ Time Frame: 12 months ]
  12. cortisol level [ Time Frame: 12 months ]
  13. Ophthalmologic exam [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02180672

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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Carole L Marcus, MBBCh Children's Hospital of Philadelphia
Additional Information:
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Responsible Party: Children's Hospital of Philadelphia Identifier: NCT02180672    
Other Study ID Numbers: 14-010942
R01HL120909 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Keywords provided by Children's Hospital of Philadelphia:
Obstructive sleep apnea syndrome
sleep apnea
nasal steroids
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Nervous System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents