Surgical Treatment of Mild Obstructive Sleep Apnea
The Effects of Surgical Treatment on Mild Obstructive Sleep Apnea and Its Co-morbidities
1 other identifier
interventional
100
1 country
1
Brief Summary
Obstructive sleep apnea (OSA) is one of the most common sleep disorder. There are numerous conditions that are related to OSA, such as diabetes, cardiovascular diseases, and metabolic syndrome. If the patient with OSA have large tonsils, soft and largened uvula or flacid soft palate, one might benefit from operative treatment of OSA. The aim of our study is to find out whether an operative treatment is effective in mild OSA patients with carefully assessed anatomical predispositions. Our ultimate goal is to evaluate the effects of operative treatment in mild OSA itself and in the diseases related to OSA. We measure the cardiovasculary functions, symptoms, postoperative recovery, antropometry, laboratory tests, the quality of life, the quality of sleep and the inflammatory system in sleep apnea before and after the surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2008
Longer than P75 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
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 4, 2008
CompletedFirst Posted
Study publicly available on registry
September 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 1, 2011
October 1, 2011
4.3 years
September 4, 2008
October 31, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Apnea Hypopnea Index
One year(before and after surgery)
Secondary Outcomes (1)
Quality of life
One Year
Study Arms (2)
I
ACTIVE COMPARATORII
OTHERInterventions
* Tonsillectomy * Uvulectomy * Soft palatal resection * Lifestyle counselling by physician: General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance
General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance.
Eligibility Criteria
You may qualify if:
- Age 18-65
- BMI \<35
- AHI 5-30 events/h
- Largened tonsils Grade ≥1
You may not qualify if:
- Age \<18 or \> 65
- BMI \>35
- AHI \<5 or \>30
- Tonsil size \< 1
- Severe nasal polyposis
- Pregnancy
- Chronic kidney, liver or thyroid disease
- Active treatment of OSA of any kind
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kuopio University Hospital
Kuopio, 70300, Finland
Related Publications (1)
Makkonen J, Blomster H, Raappana A, Markkanen S, Numminen J, Kivekas I, Valtonen O, Rautiainen M, Tuomilehto H. Adult obstructive sleep apnea treated with tonsillectomy: a randomized controlled clinical trial. Acta Otolaryngol. 2025 Oct;145(10):989-996. doi: 10.1080/00016489.2025.2557566. Epub 2025 Sep 16.
PMID: 40957567DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
September 4, 2008
First Posted
September 5, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 1, 2011
Record last verified: 2011-10