Medical vs Surgical Treatment in OSA Among Children

Phase 4

• Conditions: To Determine Clinical Response to Montelukast or Nasal Steroids Based on PSQ Results; To Evaluate PSQ as Clinical Tool in the Decision Between Medical and Surgical Treatment for Adenotonsillar Hypertrophy
• Interventions: Drug: Fluticasone Furoate; Drug: Montelukast

• Registration Number: NCT05651750
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study Start: 2022-11-15
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-15
• Last Update Posted: 2022-12-15
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone nasal spray	Fluticasone Furoate	-
Montelukast tab	Montelukast	-

Primary Outcome Measures

Name	Time	Method
To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy	1 year

Secondary Outcome Measures

Name	Time	Method
To determine clinical response to montelukast or nasal steroids based on PSQ results	1 year

Trial Locations

Locations (1)

Assaf-Harofeh Medical Center; 🇮🇱 Be'er Ya'aqov, Israel