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Medical vs Surgical Treatment in OSA Among Children

NCT ID: NCT05651750

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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Conditions

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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

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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Singulair Avamys

Eligibility Criteria

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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

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Assaf-Harofeh Medical Center

Be’er Ya‘aqov, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Sarah Rothman, MD

Role: CONTACT

Phone: +972-545743365

Email: [email protected]

Facility Contacts

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Sarah Rothman, MD

Role: primary

Other Identifiers

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Assaf-HarofehMC

Identifier Type: -

Identifier Source: org_study_id