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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Sleep Apnea Syndromes; Tonsillar Hypertrophy
• Interventions: Device: Polysomnography

• Registration Number: NCT05049369
• Lead Sponsor: Turku University Hospital

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.

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-20
• Study Start: 2022-01-25
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polysomnography for all participants of the study	Polysomnography	Polysomnography device is used to measure certain variables overnight when a participant is sleeping

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life measured by Epworth sleepiness scale (ESS)	3-17 years	Questions regarding sleepiness. Score 0-24, lower is better.
Quality of life measured by Glasgow Benefit Inventory (GBI)	3-17 years	General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.
Apnea-index (AI)	3-17 years	Post-operative apnea index reduction compared to preoperative values in polysomnography.
Oxygen Desaturation Index (ODI)	3-17 years	Post-operative reduction of oxygen desaturation index compared to preoperative values in polysomnography
Snoring time	3-17 years	Post-operative reduction of snoring time compared to preoperative values in polysomnography

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Southwest Finland, Finland