Medical vs Surgical Treatment in OSA Among Children
Primary Purpose
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
Status
Recruiting
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Montelukast
Fluticasone Furoate
Sponsored by
About this trial
This is an interventional treatment trial for To Evaluate PSQ as Clinical Tool in the Decision Between Medical and Surgical Treatment for Adenotonsillar Hypertrophy
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).
Sites / Locations
- Assaf-Harofeh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Montelukast tab
Fluticasone nasal spray
Arm Description
Outcomes
Primary Outcome Measures
To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy
Secondary Outcome Measures
To determine clinical response to montelukast or nasal steroids based on PSQ results
Full Information
NCT ID
NCT05651750
First Posted
December 7, 2022
Last Updated
December 7, 2022
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05651750
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Montelukast tab
Arm Type
Experimental
Arm Title
Fluticasone nasal spray
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
Singulair
Intervention Description
receiving 2 months treatment with Montelukast once a day
Intervention Type
Drug
Intervention Name(s)
Fluticasone Furoate
Other Intervention Name(s)
Avamys
Intervention Description
receiving 2 months treatment with Fluticasone Furoate nasal spray once a day
Primary Outcome Measure Information:
Title
To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To determine clinical response to montelukast or nasal steroids based on PSQ results
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Rothman, MD
Phone
+972-545743365
Email
sarirothman@hotmail.com
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Be'er Ya'aqov
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Rothman, MD
12. IPD Sharing Statement
Learn more about this trial
Medical vs Surgical Treatment in OSA Among Children
We'll reach out to this number within 24 hrs