Study of nasal steroid spray treatment on the quality of life and sleep parameters in children with sleep disorder breathing.

Phase 1

Conditions: Sleep disordered breathing due to enlarged tonsils and/or adenoid
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2013-004620-10-SE

Lead Sponsor: Johan Hellgren

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Children 4-10 years old
Valid address in Sweden 2015-16
Snoring and/or apneas during at least 3 months

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Lack of ability to read and write Swedish
Acute respiratory infection
Use of nasal or systemic corticosteroids or antibiotics within 4 wks prior to study
Prior tonsil or adenoid surgery
History of craniofacial, neuromuscular or genetic disorders
Severe obstructive sleep apnea (OSA) requiring urgent surgery
No interest in participating in study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of the study is to evaluate the effect of nasal steroid spray on health related quality of life in children with sleep disorder breathing<br><br>;Secondary Objective: To evaluate improvement in objective sleep parameters such as Anea-hyponea-index (AHI) and oxygen desaturation index (ODI), time of snoring during sleep.<br><br>To evaluate a standardised protocol for assessing children with suspected SDB including health related quality of life and objective sleep parameters.<br><br>;Primary end point(s): Change in OSA-18 scores after treatment;Timepoint(s) of evaluation of this end point: After 6 weeks<br>treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in PSG results after treatment (AHI, ODI)<br> Change in adenoid (photo documented measurements) and tonsil size (Brodsky score) after treatment. ;Timepoint(s) of evaluation of this end point: after 6 weeks<br>treatment