OSA in Children Referred for Adenotonsillectomy | NCT02233166

Studies
OSA in Children Referred for Adenotonsillectomy

NCT02233166

Sponsor

Lovisenberg Diakonale Hospital

Status

Unknown status

Last Update Posted

Aug 23, 2017Actual

Enrollment

115Estimated

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Aug 13, 2014

First Submission Date that Met QC Criteria

Sep 5, 2014

First Posted Date

Sep 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2017

Last Update Posted Date

Aug 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

115Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Quality of life	Questionnaire	Up to 2 years
Risk factors of OSA	Questionnaire	Up to 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

craniofacial anomalies
neurological diseases
neuropsychiatric diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lovisenberg Diakonale Hospital	Recruiting	Oslo		0456	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32402922	Derived	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.

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases