OSA in Children Referred for Adenotonsillectomy

Obstructive Sleep Apnea Clinical Trial

Official title:

Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02233166
• Other study ID #: 2012/1117
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2014
• Last updated: August 22, 2017
• Start date: August 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: Lovisenberg Diakonale Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first choice of treatment. Studies in recent years have shown that the procedure does not always have the expected effect. Children with OSA are at greater risk for complications from the procedure.

There is disagreement regarding the need for sleep studies in children prior to surgery in order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography (PSG).

The main purpose of this study is to describe the prevalence of OSA among children referred for adenotonsillectomy.

The investigators will also examine these children prior to and six months after surgery to assess their sleep pattern and quality of life.

The project outcome aims to improve the precision and quality of diagnosis and the short and long term effects of treatment of children with OSA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

• age 2-5 year

• referred for adenoidectomy and/or tonsillectomy

Exclusion Criteria:

• craniofacial anomalies

• neurological diseases

• neuropsychiatric diseases

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Norway	Lovisenberg Diakonale Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Questionnaire	Up to 2 years
Other	Risk factors of OSA	Questionnaire	Up to 2 years
Other	Post operative complications	Questionnaire; pulse oximetry	Up to 2 years
Primary	Prevalence of OSA	Apne hypopne index (AHI)/ respiratory disturbance index (RDI)	Up to 2 years
Secondary	Post operative PSG results	Apne hypopne index (AHI)/ respiratory disturbance index (RDI)	Up to 2 years