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NCT05049369 Clinical Trial

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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05049369
Other study ID # T205/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2022
Est. completion date December 4, 2022

Study information
Verified date December 2023
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date December 4, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Polysomnography
Polysomnography is performed one time overnight

Locations
Country Name City State
Finland Turku University Hospital Turku Southwest Finland

Sponsors (1)
Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Apnea-hypopnea index Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography. 3-17 years
Secondary 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
Secondary Quality of life measured by Epworth sleepiness scale (ESS) Questions regarding sleepiness. Score 0-24, lower is better. 3-17 years
Secondary Apnea-index (AI) Post-operative apnea index reduction compared to preoperative values in polysomnography. 3-17 years
Secondary Snoring time Post-operative reduction of snoring time compared to preoperative values in polysomnography 3-17 years
Secondary Oxygen Desaturation Index (ODI) Post-operative reduction of oxygen desaturation index compared to preoperative values in polysomnography 3-17 years
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