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
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography
Drug: Mometasone furoate nasal spray
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy

Resource links provided by NLM:


Further study details as provided by Children's & Women's Health Centre of British Columbia:

Primary Outcome Measures:
  • Apnea Hypopnea Index (AHI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    This wil be measured by polysomnography.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Placebo Comparator: Saline
The placebo group will receive saline nasal sprays for 8 weeks.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT01671852

Contacts
Contact: Rachelle Dar Santos-Moshfeghi, Bachelor 604-822-4872 Rachelle.DarSantos@cw.bc.ca

Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
  More Information

No publications provided

Responsible Party: Neil Chadha, Dr. Neil K. Chadha MBChB(Hons),MPHe BSc(Hons),FRCS, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier: NCT01671852     History of Changes
Other Study ID Numbers: H12-01653
Study First Received: July 5, 2012
Last Updated: August 21, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Apnea
Hypertrophy
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathological Conditions, Anatomical
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 20, 2014