Clinical trial NCT02180672: Steroids for Pediatric Apnea Research in Kids
Official title: Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Obstructive sleep apnea syndrome
OSA
sleep apnea
nasal steroids
corticosteroids
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-07-03
Enrollment: 211
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Obstructive Apnea Hypopnea Index
timeFrame: 3 months
Secondary outcomes:
measure: OAHI
timeFrame: 12 months
measure: Nasal Obstruction Symptom Evaluation (NOSE)
timeFrame: 12 months
measure: The Epworth Sleepiness Scale
timeFrame: 12 months
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 12 month
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: 12 months
measure: Conners Abbreviated Symptom Questionnaire
timeFrame: 12 months
measure: Purdue Peg Board
timeFrame: 12 months
measure: Conners Continuous Performance Test (CPT)
timeFrame: 12 months
measure: Child Behavior Checklist
timeFrame: 12-Months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Carole L Marcus, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tapia IE, Shults J, Cielo CM, Kelly AB, Elden LM, Spergel JM, Bradford RM, Cornaglia MA, Sterni LM, Radcliffe J. A Trial of Intranasal Corticosteroids to Treat Childhood OSA Syndrome. Chest. 2022 Oct;162(4):899-919. doi: 10.1016/j.chest.2022.06.026. Epub 2022 Jun 30.