Clinical trial NCT05651750: Medical vs Surgical Treatment in OSA Among Children
Official title: Medical vs Surgical Treatment Decision in Pediatric Obstructive Sleep Apnea Using Sleep Questionnaire
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: To Evaluate PSQ as Clinical Tool in the Decision Between Medical and Surgical Treatment for Adenotonsillar Hypertrophy
To Determine Clinical Response to Montelukast or Nasal Steroids Based on PSQ Results
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-12-15
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adeno-tonsillar hypertrophy causing OSA are treated surgically however, over the last years it has been shown that montelukast or nasal steroidal spray can significantly improve symptoms, adenoid size, and polysomnographic results in pediatric non-severe OSA, excluding the need for surgery. A literature review from 2016 suggested that by using anti-leukotrienes as anti-inflammatory appears to be beneficial in children with a non-severe OSA and can be offered to parents as a treatment option before, or instead of surgery. In addition, nasal steroidal spray may be considered useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy \[9\]. Despite emerging evidence that both montelukast and nasal steroids are effective in the treatment of pediatric SDB, further evidence is still required. . adeno-tonsillar hypertrophy causing OSA are treated surgically however, over the last years it has been shown that montelukast or nasal steroidal spray can significantly improve symptoms, adenoid size, and polysomnographic results in pediatric non-severe OSA, excluding the need for surgery. A literature review from 2016 suggested that by using anti-leukotrienes as anti-inflammatory appears to be beneficial in children with a non-severe OSA and can be offered to parents as a treatment option before, or instead of surgery. In addition, nasal steroidal spray may be considered useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy. Despite emerging evidence that both montelukast and nasal steroids are effective in the treatment of pediatric SDB, further evidence is still required.


Eligibility criteria: Inclusion Criteria:

* children between 2-16 years of age referred to the pediatric otolaryngology outpatient clinic due to OSA and have not undergone previous adeno-tonsillar procedure

Exclusion Criteria:

* children with severe OSA who need an urgent surgery and cannot be postponed, children with nasal polyposis, craniofacial malformations (e.g. cleft lip and palate), and genetic diseases (e.g. Down syndrome).

Primary outcomes:
measure: To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy
timeFrame: 1 year
Secondary outcomes:
measure: To determine clinical response to montelukast or nasal steroids based on PSQ results
timeFrame: 1 year
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
References: