Long-term Results of Tonsillectomy in the Treatment of Ob... | NCT05049369

Studies
Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults

NCT05049369

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

Dec 26, 2023Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea
Tonsillar Hypertrophy
Sleep Apnea Syndromes

Interventions

Polysomnography

Countries

Finland

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2022Actual

Primary Completion Date

Oct 1, 2022Actual

Completion Date

Dec 4, 2022Actual

First Submitted Date

Sep 10, 2021

First Submission Date that Met QC Criteria

Sep 10, 2021

First Posted Date

Sep 20, 2021Actual

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

Dec 22, 2023

Last Update Posted Date

Dec 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults

Detailed Description

The investigators are studying long-term efficiency of tonsillectomy in adults with obstructive sleep apnea caused by tonsillar hypertrophy. These patients have undergone tonsillectomy in 2004-2018 and now 3-17 years later investigators will perform new polysomnographies and compare these results with preoperative values. Especially the reduction in apnea-hypopnea index (AHI) will be evaluated. The quality of life and possible symptoms will be measured with questionnaires.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Polysomnography for all participants of the study	Experimental	Polysomnography device is used to measure certain variables overnight when a participant is sleeping	Device: Polysomnography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polysomnography	Device	Polysomnography is performed one time overnight	Polysomnography for all participants of the study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Apnea-hypopnea index	Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography.	3-17 years

Secondary Outcomes

Measure	Description	Time Frame
Quality of life measured by Glasgow Benefit Inventory (GBI)	General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.	3-17 years
Quality of life measured by Epworth sleepiness scale (ESS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age at least 16 during tonsillectomy
preoperative obstructive sleep apnea and AHI (apnea-hypopnea index) > 14
tonsillectomy has been done because of the symptoms caused by tonsillar hypertrophy (ICD-10 diagnostic codes G47.3, R06.5 or J35.1)
in addition to tonsillectomy, patients may have undergone shortening of uvula and/or radio frequency ablation of soft palate

Exclusion Criteria:

AHI < 14
in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement
other, evaluated by investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaakko M Piitulainen, MD,PhD	Department of Otorhinolaryngology, Turku University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku University Hospital		Turku	Southwest Finland	20521	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017286	Polysomnography

Ancestor Terms

ID	Term
D008991	Monitoring, Physiologic
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided