The Effect of Tympanostomy Tube Insertion on Sleep in Chi... | NCT02477735

Studies
The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion

NCT02477735

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jun 23, 2015Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Chronic Otitis Media With Effusion
Sleep Disturbances

Interventions

Actigraphy

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Aug 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

May 21, 2015

First Submission Date that Met QC Criteria

Jun 17, 2015

First Posted Date

Jun 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Device: Actigraphy
Healthy infants		Healthy infants that were recruited from the community well-baby clinics.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Actigraphy	Device	Actigraphy will be conducted for each participant for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Actigraphy measurements		Up to two years

Secondary Outcomes

Measure	Description	Time Frame
OSA-18 questionnaire score		Up to two years
Brief Infant Sleep Questionnaire (BISQ) score		Up to two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

36 Months

Standard Ages

Child

Study Population

Infants with COME who will be referred for TTI.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gad Fishman, Doctor	Contact	+972-2-4266362		gadf@tlvmc.gov.il

Overall Officials

Name	Affiliation	Role
Gad Fishman, Doctor	Dana Children's Hospital, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine Tel-Aviv Univesity, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"DANA" children's hospital		Tel Aviv			Israel

Condition Browse Module

MeSH Terms

ID	Term
D020447	Parasomnias

Ancestor Terms

ID	Term
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D056044	Actigraphy

Ancestor Terms

ID	Term
D008991	Monitoring, Physiologic
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D061725	Accelerometry

Browse Leaves

Not provided

Browse Branches

Not provided