Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy (Nasonex OSA)
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ClinicalTrials.gov Identifier: NCT01671852 |
Recruitment Status :
Withdrawn
(Could not obtain funding.)
First Posted : August 24, 2012
Last Update Posted : July 30, 2015
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Condition or disease | Intervention/treatment | Phase |
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Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography | Drug: Mometasone furoate nasal spray Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
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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.
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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.
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Drug: Placebo |
- Apnea Hypopnea Index (AHI) [ Time Frame: 8 weeks ]This wil be measured by polysomnography.
- 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) ]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) ]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) ]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) ]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) ]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) ]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) ]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) ]This will be measured by polysomnography.

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Ages Eligible for Study: | 3 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 ClinicalTrials.gov identifier (NCT number): NCT01671852
Canada, British Columbia | |
BC Women's and Children's Hospital | |
Vancouver, British Columbia, Canada, V6H 3N1 |
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 |
Other Study ID Numbers: |
H12-01653 |
First Posted: | August 24, 2012 Key Record Dates |
Last Update Posted: | July 30, 2015 |
Last Verified: | July 2015 |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Hypertrophy Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Dyssomnias Sleep Wake Disorders Nervous System Diseases Pathological Conditions, Anatomical Mometasone Furoate Anti-Inflammatory Agents Dermatologic Agents Anti-Allergic Agents |