Clincosm LogoSign in Get a demo

Medical vs Surgical Treatment in OSA Among Children

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05651750
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
7.5
Anticipated Duration (Months)
12.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Medical vs Surgical Treatment Decision in Pediatric Obstructive Sleep Apnea Using Sleep Questionnaire
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Montelukast tab

Drug: Montelukast
receiving 2 months treatment with Montelukast once a day
Other Names:
  • Singulair

    		•
    Experimental: Fluticasone nasal spray

    Drug: Fluticasone Furoate
    receiving 2 months treatment with Fluticasone Furoate nasal spray once a day
    Other Names:
  • Avamys

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy [1 year]

    Secondary Outcome Measures

    1. To determine clinical response to montelukast or nasal steroids based on PSQ results [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assaf-Harofeh Medical Center Be'er Ya'aqov Israel

    Sponsors and Collaborators

    • Assaf-Harofeh Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assaf-Harofeh Medical Center
    ClinicalTrials.gov Identifier:
    NCT05651750
    Other Study ID Numbers:
    • Assaf-HarofehMC
    First Posted:
    Dec 15, 2022
    Last Update Posted:
    Dec 15, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Hypertrophy
    Fluticasone
    Xhance
    Montelukast

    Study Results

    No Results Posted as of Dec 15, 2022