Chronic Otitis Media With Effusion, Sleep Disturbances
Conditions
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.
Interventions
DEVICEActigraphy
Actigraphy will be conducted for each participant for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
* Age: 6-36 months * Referred for tympanostomy tube insertion as a treatment for COME.
Exclusion criteria
* Snoring and sleep disordered breathing (SDB) * Chronic medical condition * referred for TTI and adenoidectomy/tonsillectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Actigraphy measurements | Up to two years |
Secondary
| Measure | Time frame |
|---|---|
| OSA-18 questionnaire score | Up to two years |
| Brief Infant Sleep Questionnaire (BISQ) score | Up to two years |
Countries
Israel
Contacts
Primary ContactGad Fishman, Doctor
Outcome results
None listed