Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-30 @ 4:17 AM
Study NCT ID:
NCT02233166
Status:
UNKNOWN
Last Update Posted:
2017-08-23
First Post:
2014-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OSA in Children Referred for Adenotonsillectomy
Sponsor:
Lovisenberg Diakonale Hospital
Organization:
Study Overview
Official Title:
Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: