Status:
UNKNOWN
Surgical Versus Nonsurgical Treatment on Quality of Life for Children With Controversial OSA Diagnoses
Lead Sponsor:
Beijing Tongren Hospital
Collaborating Sponsors:
Beijing Children's Hospital
Shanghai 6th People's Hospital
Conditions:
Obstructive Sleep Apnea of Child
Eligibility:
All Genders
2-14 years
Phase:
NA
Brief Summary
Obstructive sleep apnea (OSA) is a disease characterized by repeated partial or complete upper airway collapse during sleep, accompanied by arousals or oxygen desaturation. It was reported to affect 5...
Detailed Description
Obstructive sleep apnea (OSA) is a disease characterized by repeated partial or complete upper airway collapse during sleep, accompanied by arousals or oxygen desaturation. It was reported to affect 5...
Eligibility Criteria
Inclusion
- Aged between 2 to 14 years
- Complaints of habitual sleep snoring, apnea, mouth breathing, daytime somnolence
- ATS positive (AHI \> 5/H or OAI \> 1/H) \& ICSD-3 negative (OAHI \< 1/H) or ATS negative (AHI ≤5 /H or OAI ≤ 1/H) \& ICSD-3 positive (OAHI ≥ 1/H)
Exclusion
- Aged below 2 or above 14 years
- Unconscious
- Facial dysplasia
- Neuro-psychological diseases
- Having taken spirit or nervous system drugs within 3 months
- Diagnosed with acromegaly, hypothyroidism, vocal cord paralysis, laryngeal spasm, epilepsy， narcolepsy or neuromuscular disease
- Having received systematic treatment for OSA (having used a ventilator for more than 1 month, or having received adenotonsillectomy.)
- Caregivers did not fill out the questionnaire either pre or postoperatively
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03370731
Start Date
January 1 2016
End Date
September 1 2018
Last Update
December 14 2017
Active Locations (4)
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1
Beijing Children's Hospital
Beijing, Beijing Municipality, China, 100000
2
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730
3
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
4
Shanghai 6th People Hospital
Shanghai, Shanghai Municipality, China