The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion
- Conditions
- Chronic Otitis Media With EffusionSleep Disturbances
- Registration Number
- NCT02477735
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- Brief Summary
The purpose of this study is to investigate the prevalence of sleep disturbances in children with Chronic Otitis Media with Effusion (COME) and the effect of tympanostomy tube insertion (TTI) on sleep disturbances.
- Detailed Description
Comparison of sleep disturbances will be between infants with Chronic Otitis Media with Effusion (COME) who will be referred for tympanostomy tube insertion (TTI) (study group) and healthy infants that were recruited from the community well-baby clinics (control group).
To evaluate sleep patterns, parents of the study group will complete two validated sleep questionnaires assessing the infant's typical sleep patterns based on parental reports. A week before TTI and 1 week to 1 month after the surgery, sleep will be evaluate by actigraph for a week long.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Age: 6-36 months
- Referred for tympanostomy tube insertion as a treatment for COME.
- Snoring and sleep disordered breathing (SDB)
- Chronic medical condition
- referred for TTI and adenoidectomy/tonsillectomy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Actigraphy measurements Up to two years
- Secondary Outcome Measures
Name Time Method Brief Infant Sleep Questionnaire (BISQ) score Up to two years OSA-18 questionnaire score Up to two years
Trial Locations
- Locations (1)
"DANA" children's hospital
🇮🇱Tel-Aviv, Israel
"DANA" children's hospital🇮🇱Tel-Aviv, Israel