The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 23, 2015
May 1, 2015
2.2 years
May 21, 2015
June 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Actigraphy measurements
Up to two years
Secondary Outcomes (2)
OSA-18 questionnaire score
Up to two years
Brief Infant Sleep Questionnaire (BISQ) score
Up to two years
Study Arms (2)
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.
Healthy infants
Healthy infants that were recruited from the community well-baby clinics.
Interventions
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
Infants with COME who will be referred for TTI.
You may qualify if:
- Age: 6-36 months
- Referred for tympanostomy tube insertion as a treatment for COME.
You may not qualify if:
- Snoring and sleep disordered breathing (SDB)
- Chronic medical condition
- referred for TTI and adenoidectomy/tonsillectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
"DANA" children's hospital
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gad Fishman, Doctor
Dana Children's Hospital, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine Tel-Aviv Univesity, Israel
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2015
First Posted
June 23, 2015
Study Start
June 1, 2015
Primary Completion
August 1, 2017
Study Completion
December 1, 2017
Last Updated
June 23, 2015
Record last verified: 2015-05