Follow-up Studies of Primary Snoring(PS) and Obstructive Sleep Apnea Hypopnea Syndrome(OSAHS) in Chinese Children

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Capital Medical University

Status

Completed

Conditions

Obstructive Sleep Apnea Syndrome

Treatments

Procedure: Adenotonsillectomy
Other: Conservative treatment
Other: no treatment

Study type

Observational

Funder types

Other

Identifiers

NCT02447614
BCH-OSAHS-002

Details and patient eligibility

About

The study is designed to investigate the natural course of Primary snoring in 1-2 years or more and the different effect of drug and surgical treatment applied in children with obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires in 6 months after treatment.

Full description

The evolution of snoring and OSAS in children is not well established since few studies have been published.This study is designed to evaluate the evolution of primary snoring and OSAS in children who had been submitted to watchful waiting 、drug or adenotonsillectomy.The participated children will be evaluated by full physical examination and nocturnal polysomnography(PSG), after which they were divided into 2 groups: apnea and snoring. After 6 months following the initial evaluation, patients were submitted to a new nocturnal polysomnography, and all data were compared to those of the first examination.And after 3 months and 12 months following the initial evaluation, patients will be called to complete the sleep questionnaire.Then analyse the change of parameters of polysomnography after 6 months of follow-up,and describe the changes of items of sleep questionnaire.

Enrollment

500 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram.

Exclusion criteria

  • Children who are suffered from any chronic medical or psychiatric condition
  • Children with acute respiratory infection
  • Children with severe craniofacial deformities
  • Children with cardiopulmonary diseases
  • Children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate

Trial design

500 participants in 3 patient groups

Surgery
Description:
Adenotonsillectomy
Treatment:
Procedure: Adenotonsillectomy
Conservative treatment
Description:
Mometasone Furoate Aqueous Nasal Spray or uticasone propionate (1/once qd) and(or)Leukotriene antagonists(4 or 5mg/once qn) or H1 receptor antagonists
Treatment:
Other: Conservative treatment
no treatment
Description:
just regular follow-up
Treatment:
Other: no treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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