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

NCT ID: NCT05049369

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2022-12-04

Brief Summary

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

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea Tonsillar Hypertrophy Sleep Apnea Syndromes

Keywords

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tonsillectomy obstructive sleep apnea tonsil surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Polysomnography for all participants of the study

Polysomnography device is used to measure certain variables overnight when a participant is sleeping

Group Type EXPERIMENTAL

Polysomnography

Intervention Type DEVICE

Polysomnography is performed one time overnight

Interventions

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Polysomnography

Polysomnography is performed one time overnight

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaakko M Piitulainen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Otorhinolaryngology, Turku University Hospital

Locations

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Turku University Hospital

Turku, Southwest Finland, Finland

Site Status

Countries

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Finland

Other Identifiers

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T205/2021

Identifier Type: -

Identifier Source: org_study_id