Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
1 other identifier
interventional
17
1 country
1
Brief Summary
Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2021
CompletedFirst Posted
Study publicly available on registry
September 20, 2021
CompletedStudy Start
First participant enrolled
January 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2022
CompletedDecember 26, 2023
December 1, 2023
8 months
September 10, 2021
December 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Apnea-hypopnea index
Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography.
3-17 years
Secondary Outcomes (5)
Quality of life measured by Glasgow Benefit Inventory (GBI)
3-17 years
Quality of life measured by Epworth sleepiness scale (ESS)
3-17 years
Apnea-index (AI)
3-17 years
Snoring time
3-17 years
Oxygen Desaturation Index (ODI)
3-17 years
Study Arms (1)
Polysomnography for all participants of the study
EXPERIMENTALPolysomnography device is used to measure certain variables overnight when a participant is sleeping
Interventions
Polysomnography is performed one time overnight
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- AHI \< 14
- in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement
- other, evaluated by investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turku University Hospital
Turku, Southwest Finland, 20521, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaakko M Piitulainen, MD,PhD
Department of Otorhinolaryngology, Turku University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2021
First Posted
September 20, 2021
Study Start
January 25, 2022
Primary Completion
October 1, 2022
Study Completion
December 4, 2022
Last Updated
December 26, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share