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Completed

NCT Number: NCT05049369

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

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Tonsillar Hypertrophy

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, Southwest Finland, 20521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Device

Polysomnography is performed one time overnight

Primary outcomes

  1. Apnea-hypopnea index

    Time frame: 3-17 years

    Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography.

Secondary outcomes

  1. Quality of life measured by Glasgow Benefit Inventory (GBI)

    Time frame: 3-17 years

    General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.

  2. Quality of life measured by Epworth sleepiness scale (ESS)

    Time frame: 3-17 years

    Questions regarding sleepiness. Score 0-24, lower is better.

  3. Apnea-index (AI)

    Time frame: 3-17 years

    Post-operative apnea index reduction compared to preoperative values in polysomnography.

  4. Snoring time

    Time frame: 3-17 years

    Post-operative reduction of snoring time compared to preoperative values in polysomnography

  5. Oxygen Desaturation Index (ODI)

    Time frame: 3-17 years

    Post-operative reduction of oxygen desaturation index compared to preoperative values in polysomnography

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2021
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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