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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02477735
Study type Observational
Source Tel-Aviv Sourasky Medical Center
Contact Gad Fishman, Doctor
Phone +972-2-4266362
Email gadf@tlvmc.gov.il
Status Not yet recruiting
Phase N/A
Start date June 2015
Completion date December 2017

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