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

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Chronic Otitis Media With Effusion
Sleep Disturbances

Treatments

Device: Actigraphy

Study type

Observational

Funder types

Other

Identifiers

NCT02477735
TASMC-15-GF-0021-15-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 36 months old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Study group
Description:
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.
Treatment:
Device: Actigraphy
Healthy infants
Description:
Healthy infants that were recruited from the community well-baby clinics.

Trial contacts and locations

0

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Central trial contact

Gad Fishman, Doctor

Data sourced from clinicaltrials.gov

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