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Surgical Treatment of Mild Obstructive Sleep Apnea

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Henry Blomster, Kuopio University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Henry Blomster, Kuopio University Hospital Identifier:
First received: September 4, 2008
Last updated: October 31, 2011
Last verified: October 2011
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 Intervention
Sleep Apnea Procedure: Modified tonsillectomy Other: Lifestyle counselling by physician

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Henry Blomster, Kuopio University Hospital:

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

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

Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00747890

Contact: Henry Blomster, MD +358447172513

Kuopio University Hospital Recruiting
Kuopio, Finland, 70300
Contact: Henry Blomster, MD   
Sponsors and Collaborators
Kuopio University Hospital
  More Information

Responsible Party: Henry Blomster, PhD, Kuopio University Hospital Identifier: NCT00747890     History of Changes
Other Study ID Numbers: KUH5551817
Study First Received: September 4, 2008
Last Updated: October 31, 2011

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on September 19, 2017