None listed
Conditions
Brief summary
Breathing problems in sleep (known as sleep disordered breathing - SDB) is a common problem in childhood (seen in up to 10%). SDB can affect children along a spectrum from snoring without sleep disruption, to obstructive sleep apnoea (OSA) with severely disrupted sleep and pauses in breathing. SDB symptoms are now the most common reason for tonsillectomy surgery in children. However, some of these children may benefit from less invasive medical treatment. This study is trying to find out if a nasal steroid spray (INS) (mometasone furoate) can help reduce SDB symptoms. We will ask children 3-12years old to be part of the study. We will do an examination and ask parents to complete questionnaires on their child’s SDB symptoms, and other things related to good sleep such as their child’s emotions and behaviour, and quality of life. We will give them either INS or saline spray (salty water) for 6 weeks, and then repeat the assessments to see the effect of the INS versus saline. We will also monitor who has surgery over the next two years. We expect that INS will reduce the symptoms of SDB, and ultimately reduce the need for surgery, thereby improving the health and quality of life of children with SDB, and also reducing health care costs.
Interventions
mometasone furoate 50 micrograms / spray; 1 spray each nostril daily for 6 weeks
Adherence will be assessed by weight of medication bottles prior to dispensing and on return after the 6 week intervention period.
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 3 to 12 years of age, referred to Upper Airways, Sleep, Respiratory and Ear Nose Throat (ENT) clinics at the Royal Children’s Hospital (RCH) and Sleep and ENT clinic at Monash Medical Centre (MMC) will be screened by telephone for symptoms of SDB • Children with a Brouillette score =/> -1 will be eligible
Exclusion criteria
Children will be excluded if: • BMI > 97th centile • Stertor while awake and at rest • Past Tonsillectomy and/or Adenoidectomy • Craniofacial, neuromuscular, syndromic or defined genetic disorders • Haemorrhagic diathesis or recurrent nosebleeds • Use of intranasal or systemic corticosteroid within the past 6 weeks • Active nasal infection or nasal trauma not fully healed • Active tonsillitis
Outcome results
None listed