Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children
| Status: | Terminated |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 2 - 10 |
| Updated: | 4/21/2016 |
| Start Date: | July 2010 |
| End Date: | August 2014 |
A Randomized Double Blind Controlled Trial on the Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
The investigators leading hypotheses are:
- Oral therapy with montelukast may lead to improved sleep study findings in children
with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical
removal of adenoids and tonsils for OSAS.
- A significant proportion of the children with OSAS treated with montelukast will show
reduced severity of OSAS, and this will remove the need for surgical intervention.
- Oral therapy with montelukast may lead to improved sleep study findings in children
with mild to moderate Obstructive Sleep Apnea Syndrome (OSAS) who require surgical
removal of adenoids and tonsils for OSAS.
- A significant proportion of the children with OSAS treated with montelukast will show
reduced severity of OSAS, and this will remove the need for surgical intervention.
Inclusion Criteria:
- Eligible for inclusion in the study will be symptomatic snoring children >2 years of
age and < 10 years of age, who snore and have an apnea hypopnea index (AHI) >2/hrTST
(hour total sleep time), and in whom T&A is therefore contemplated. Also among these,
we will include children referred for evaluation for snoring who have a history of
allergic rhinitis.
Exclusion Criteria:
- Exclusion criteria will include: Hypersensitivity to montelukast, immunodeficiency or
immunosuppressant therapy, craniofacial, neuromuscular, syndromic or defined genetic
abnormalities, acute upper respiratory tract infection, systemic corticosteroid
therapy or antibiotic therapy in the 2 weeks previous to the study, and children who
already had adenotonsillectomy. In addition, children chronically receiving oral
antihistamine preparations or nasal decongestants will be required to continue using
these medications throughout the duration of the study. Patients receiving
immunotherapy will continue on the same regimen without escalation of dose and
frequency throughout the duration of the study. In addition, patients with severe OSA
who in the opinion of their treating physicians require early surgical intervention
for their OSA will be excluded from eligibility to the study.
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