- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02477735
The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Gad Fishman, Doctor
- Phone Number: +972-2-4266362
- Email: gadf@tlvmc.gov.il
Study Locations
-
-
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Tel-Aviv, Israel
- "DANA" children's hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Actigraphy will be conducted for each participant for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.
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Healthy infants
Healthy infants that were recruited from the community well-baby clinics.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Actigraphy measurements
Time Frame: Up to two years
|
Up to two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
OSA-18 questionnaire score
Time Frame: Up to two years
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Up to two years
|
Brief Infant Sleep Questionnaire (BISQ) score
Time Frame: Up to two years
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Up to two years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gad Fishman, Doctor, Dana Children's Hospital, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine Tel-Aviv Univesity, Israel
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-15-GF-0021-15-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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