Clinical Trials Logo
  1. Home
  2. Obstructive Sleep Apnea
  3. NCT05049369
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT05857384 - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs Phase 1
Recruiting NCT04547543 - Follow-up of Apneic Patients by Visio-consultation N/A
Recruiting NCT05371509 - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study N/A
Completed NCT02515357 - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea N/A
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Active, not recruiting NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea Phase 2
Completed NCT04084899 - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting NCT04028011 - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting NCT06047353 - Community Health Advocates for Motivating PAP Use in Our Neighborhoods. N/A
Completed NCT05253963 - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea N/A
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed NCT03589417 - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Withdrawn NCT04063436 - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting NCT04572269 - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting NCT06467682 - 12-week Tele-exercise Program in Patients With OSA N/A
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A