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Clinical Trials/NCT00747890
NCT00747890
Unknown
Not Applicable

The Effects of Surgical Treatment on Mild Obstructive Sleep Apnea and Its Co-morbidities

Kuopio University Hospital1 site in 1 country100 target enrollmentSeptember 2008
ConditionsSleep Apnea

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea
Sponsor
Kuopio University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Apnea Hypopnea Index
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
December 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Kuopio University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Henry Blomster

PhD

Kuopio University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Age \<18 or \> 65
  • AHI \<5 or \>30
  • Tonsil size \< 1
  • Severe nasal polyposis
  • Pregnancy
  • Chronic kidney, liver or thyroid disease
  • Active treatment of OSA of any kind

Outcomes

Primary Outcomes

Apnea Hypopnea Index

Time Frame: One year(before and after surgery)

Secondary Outcomes

  • Quality of life(One Year)

Study Sites (1)

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