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Surgical Treatment of Mild Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747890
Recruitment Status : Unknown
Verified October 2011 by Henry Blomster, Kuopio University Hospital.
Recruitment status was:  Recruiting
First Posted : September 5, 2008
Last Update Posted : November 1, 2011
Information provided by (Responsible Party):
Henry Blomster, 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Procedure: Modified tonsillectomy Other: Lifestyle counselling by physician Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effects of Surgical Treatment on Mild Obstructive Sleep Apnea and Its Co-morbidities
Study Start Date : September 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: I Procedure: Modified tonsillectomy
  • Tonsillectomy
  • Uvulectomy
  • Soft palatal resection
  • Lifestyle counselling by physician: General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance

II Other: Lifestyle counselling by physician
General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance.

Primary Outcome Measures :
  1. Apnea Hypopnea Index [ Time Frame: One year(before and after surgery) ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: One Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747890

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Contact: Henry Blomster, MD +358447172513

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Kuopio University Hospital Recruiting
Kuopio, Finland, 70300
Contact: Henry Blomster, MD   
Sponsors and Collaborators
Kuopio University Hospital
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Responsible Party: Henry Blomster, PhD, Kuopio University Hospital Identifier: NCT00747890    
Other Study ID Numbers: KUH5551817
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases