Surgical Treatment of Mild Obstructive Sleep Apnea

Not Applicable

• Conditions: Sleep Apnea

• 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

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-31
• Last Update Posted: 2011-11-01
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18-65
• BMI <35
• AHI 5-30 events/h
• Largened tonsils Grade ≥1

Exclusion Criteria

• 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

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