Medical vs Surgical Treatment in OSA Among Children

NCT05651750 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: Assaf-HarofehMC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy

  1 year

Secondary Outcomes (1)

• To determine clinical response to montelukast or nasal steroids based on PSQ results

  1 year

Study Arms (2)

Montelukast tab

EXPERIMENTAL

Drug: Montelukast

Fluticasone nasal spray

EXPERIMENTAL

Drug: Fluticasone Furoate

Interventions

Montelukast DRUG

receiving 2 months treatment with Montelukast once a day

Also known as: Singulair

Montelukast tab

Fluticasone Furoate DRUG

receiving 2 months treatment with Fluticasone Furoate nasal spray once a day

Also known as: Avamys

Fluticasone nasal spray

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf-Harofeh Medical Center

Be’er Ya‘aqov, Israel

RECRUITING

MeSH Terms

Interventions

montelukast; fluticasone furoate

Central Study Contacts

Sarah Rothman, MD

CONTACT

+972-545743365; sarirothman@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: November 15, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: December 15, 2022

Record last verified: 2021-12

Locations

IL (1)