The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion
NCT ID: NCT02477735
Last Updated: 2015-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2015-06-30
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Study group
Infants with COME who will be referred for TTI will undergo actigraphy for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.
Actigraphy
Actigraphy will be conducted for each participant for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.
Healthy infants
Healthy infants that were recruited from the community well-baby clinics.
No interventions assigned to this group
Interventions
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Actigraphy
Actigraphy will be conducted for each participant for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.
Eligibility Criteria
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Inclusion Criteria
* Referred for tympanostomy tube insertion as a treatment for COME.
Exclusion Criteria
* Chronic medical condition
* referred for TTI and adenoidectomy/tonsillectomy
6 Months
36 Months
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Gad Fishman, Doctor
Role: PRINCIPAL_INVESTIGATOR
Dana Children's Hospital, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine Tel-Aviv Univesity, Israel
Locations
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"DANA" children's hospital
Tel Aviv, , Israel
Countries
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Central Contacts
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Other Identifiers
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TASMC-15-GF-0021-15-CTIL
Identifier Type: -
Identifier Source: org_study_id
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