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

Sleep Disturbances Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02477735
• Other study ID #: TASMC-15-GF-0021-15-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 21, 2015
• Last updated: June 17, 2015
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2015
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Gad Fishman, Doctor
• Phone: +972-2-4266362
• Email: gadf[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Otitis Media With Effusion
• Dyssomnias
• Otitis
• Otitis Media
• Otitis Media with Effusion
• Parasomnias
• Sleep Disorders
• Sleep Disturbances

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Israel	"DANA" children's hospital	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actigraphy measurements		Up to two years	No
Secondary	OSA-18 questionnaire score		Up to two years	No
Secondary	Brief Infant Sleep Questionnaire (BISQ) score		Up to two years	No