Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy (Nasonex OSA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Children's & Women's Health Centre of British Columbia
Sponsor:
Information provided by (Responsible Party):
Neil Chadha, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier:
NCT01671852
First received: July 5, 2012
Last updated: August 21, 2012
Last verified: August 2012

July 5, 2012
August 21, 2012
September 2012
September 2013   (final data collection date for primary outcome measure)
Apnea Hypopnea Index (AHI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
This wil be measured by polysomnography.
Same as current
Complete list of historical versions of study NCT01671852 on ClinicalTrials.gov Archive Site
  • Respiratory Disturbance Index [ Time Frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention) ] [ Designated as safety issue: No ]
    This will be measured by polysomnography.
  • Desaturation index [ Time Frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention) ] [ Designated as safety issue: No ]
    This will be measured by polysomnography.
  • Respiratory arousal index [ Time Frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention) ] [ Designated as safety issue: No ]
    This will be measured by polysomnography.
  • Nadir of arterial oxygen saturation [ Time Frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention) ] [ Designated as safety issue: No ]
    This will be measured by polysomnography.
  • Mean arterial oxygen saturation [ Time Frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention) ] [ Designated as safety issue: No ]
    This will be measured by polysomnography.
  • Avoidance of surgical treatment for OSA [ Time Frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention) ] [ Designated as safety issue: No ]
    This will be measured by polysomnography.
  • Clinical symptom score (based on parent repot of, for example, snoring, witnessed apnea, daytime sleepiness etc.) [ Time Frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention) ] [ Designated as safety issue: No ]
    This will be measured by polysomnography.
  • Tonsillar size (on an ordinal scale from 0 [not visible] to +4 [tonsils touch]) [ Time Frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention) ] [ Designated as safety issue: No ]
    This will be measured by polysomnography.
Same as current
Not Provided
Not Provided
 
Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
A Randomized Controlled Trial of Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy

Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep characterized by prolonged partial upper airway obstruction and/or intermittent complete obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition occurs in 2-5% of children and can occur at any age, but it is most common in children between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease, growth delay, poor learning and behavioral problems such as inattention and hyperactivity. The most common underlying risk factor for the development of OSA is enlargement of tonsils and adenoids. Given the potential risk of complications associated with surgery of the tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to moderate OSA4. The authors recommended that further randomised controlled studies were required to evaluate the efficacy of INCSs in children with OSA. In particular they recommended that future studies should employ sleep studies to look for any improvement with INCSs, and should include children with more severe OSA, as these are the patients at the greatest risk of complications of surgery and would benefit most from a non-surgical treatment. The purpose of this study is therefore to explore the efficacy of INCSs in children with the full spectrum of OSA severity, including sleep study analysis., and longer term follow-up.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography
  • Drug: Mometasone furoate nasal spray

    Included patients will be randomized to a sequence of treatments including a medicated nasal spray and a saline nasal spray. The medicated group will receive Mometasone nasal sprays at the dosage outlined below for 8 weeks. The placebo group will receive saline nasal sprays for an equal duration. Informed consent of the parents or legal guardians will be obtained.

    For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks.

    Other Name: Nasonex
  • Drug: Placebo
  • Active Comparator: Nasonex
    The intervention group will receive mometasone nasal sprays at the dosage outlined below for 8 weeks. For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks.
    Intervention: Drug: Mometasone furoate nasal spray
  • Placebo Comparator: Saline
    The placebo group will receive saline nasal sprays for 8 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
Not Provided
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children between age 3 and 16 with objectively diagnosed OSA (mild, moderate, severe) as per polysomnography (AHI ≥ 1/h, where AHI is the sum of obstructive and mixed apneas and obstructive hypopneas).

Exclusion Criteria:

  • Children with malformation syndromes or craniofacial anomalies
  • Children with neuromuscular disorders
  • Children with morbid obesity (body mass index ≥ 40)
  • Children with asthma requiring steroid treatment
Both
3 Years to 16 Years
No
Contact: Rachelle Dar Santos-Moshfeghi, Bachelor 604-822-4872 Rachelle.DarSantos@cw.bc.ca
Not Provided
 
NCT01671852
H12-01653
No
Neil Chadha, Children's & Women's Health Centre of British Columbia
Children's & Women's Health Centre of British Columbia
Not Provided
Not Provided
Children's & Women's Health Centre of British Columbia
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP