Sponsor study identifier
observational
30
1 country
1
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2015
Actual (reported)June 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 23, 2015
Actual (reported)August 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Actigraphy measurements
Up to two years
OSA-18 questionnaire score
Up to two years
Brief Infant Sleep Questionnaire (BISQ) score
Up to two years
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 that were recruited from the community well-baby clinics.
Actigraphy will be conducted for each participant for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Infants with COME who will be referred for TTI.
"DANA" children's hospital
Tel Aviv, Israel
Gad Fishman, Doctor
Dana Children's Hospital, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine Tel-Aviv Univesity, Israel
First Submitted
May 21, 2015
First Posted
June 23, 2015
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2017
Estimated (date passed)Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder
Bonafide Sleep Supplement for Menopausal Women With Impaired Sleep
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 23, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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