OSA in Children Referred for Adenotonsillectomy

Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Anticipated): 115

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0456
    • Recruiting
    • Lovisenberg Diakonale Hospital
    • Contact: Britt Øverland, PhD; Phone Number: +4723226326; Email: brov@lds.no
    • Contact: Hanne Berdal, MD; Phone Number: +4723226381; Email: habs@lds.no
    • Principal Investigator: Britt Øverland, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children aged between 2 and 5 years who are referred for adenoidectomy and/or tonsillectomy.

Description

Inclusion Criteria:

• age 2-5 year
• referred for adenoidectomy and/or tonsillectomy

Exclusion Criteria:

• craniofacial anomalies
• neurological diseases
• neuropsychiatric diseases

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of OSA	Apne hypopne index (AHI)/ respiratory disturbance index (RDI)	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative PSG results	Apne hypopne index (AHI)/ respiratory disturbance index (RDI)	Up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Questionnaire	Up to 2 years
Risk factors of OSA	Questionnaire	Up to 2 years
Post operative complications	Questionnaire; pulse oximetry	Up to 2 years

Collaborators and Investigators

• Sponsor: Lovisenberg Diakonale Hospital

Publications and helpful links

General Publications

• Overland B, Berdal H, Akre H. Correlations between disease-specific quality of life and polysomnographic findings in children with obstructive sleep apnea. Int J Pediatr Otorhinolaryngol. 2020 Jul;134:110077. doi: 10.1016/j.ijporl.2020.110077. Epub 2020 Apr 30.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2012/1117