Medical vs Surgical Treatment in OSA Among Children

NCT ID: NCT05651750

Last Updated: 2022-12-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Montelukast tab

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

receiving 2 months treatment with Montelukast once a day

Fluticasone nasal spray

Group Type: EXPERIMENTAL

Fluticasone Furoate

Intervention Type: DRUG

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

Interventions

Montelukast

receiving 2 months treatment with Montelukast once a day

Intervention Type: DRUG

Fluticasone Furoate

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

Intervention Type: DRUG

Other Intervention Names

Singulair; Avamys

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).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assaf-Harofeh Medical Center

Be’er Ya‘aqov, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Sarah Rothman, MD

Role: CONTACT

sarirothman@hotmail.com

+972-545743365

Facility Contacts

Sarah Rothman, MD

Role: primary

Other Identifiers

Assaf-HarofehMC

Identifier Type: -

Identifier Source: org_study_id