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

A double blind, placebo controlled randomized study of nasal steroid spray treatment on the quality of life and objective sleep parameters in children with sleep disorder breathing.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004620-10-SE

Enrollment

Unknown

Registered

2014-10-16

Start date

2014-12-22

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disordered breathing due to enlarged tonsils and/or adenoid

Interventions

Trade Name: Rhinocort Aqua Product Name: Rhinocort Aqua Pharmaceutical Form: Nasal spray, suspension Pharmaceutical form of the placebo: Nasal spray, suspension Route of administration of the placebo:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 ;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. To evaluate a standardised protocol for assessing children with suspected SDB including health related quality of life and objective sleep parameters. ;Primary end point(s): Change in OSA-18 scores after treatment;Timepoint(s) of evaluation of this end point: After 6 weeks treatment	—

Measure

Time frame

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 ;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. To evaluate a standardised protocol for assessing children with suspected SDB including health related quality of life and objective sleep parameters. ;Primary end point(s): Change in OSA-18 scores after treatment;Timepoint(s) of evaluation of this end point: After 6 weeks treatment

—

Secondary

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

Countries

Sweden

Contacts

Public ContactJohan Hellgren

Johan Hellgren

johan.hellgren@gu.se0046313429147

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026