Surgical Treatment of Mild Obstructive Sleep Apnea
- Conditions
- Sleep Apnea
- Interventions
- Procedure: Modified tonsillectomyOther: Lifestyle counselling by physician
- Registration Number
- NCT00747890
- Lead Sponsor
- Kuopio University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Age 18-65
- BMI <35
- AHI 5-30 events/h
- Largened tonsils Grade ≥1
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description I Modified tonsillectomy - II Lifestyle counselling by physician -
- Primary Outcome Measures
Name Time Method Apnea Hypopnea Index One year(before and after surgery)
- Secondary Outcome Measures
Name Time Method Quality of life One Year
Trial Locations
- Locations (1)
Kuopio University Hospital
🇫🇮Kuopio, Finland