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Surgical Treatment of Mild Obstructive Sleep Apnea

This study is currently recruiting participants.
Verified October 2011 by Kuopio University Hospital
Sponsor:
Information provided by (Responsible Party):
Henry Blomster, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00747890
First received: September 4, 2008
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • Apnea Hypopnea Index [ Time Frame: One year(before and after surgery) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: One Year ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747890

Contacts
Contact: Henry Blomster, MD +358447172513 henry.blomster@kuh.fi

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland, 70300
Contact: Henry Blomster, MD         henry.blomster@kuh.fi    
Sponsors and Collaborators
Kuopio University Hospital
  More Information

No publications provided

Responsible Party: Henry Blomster, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00747890     History of Changes
Other Study ID Numbers: KUH5551817
Study First Received: September 4, 2008
Last Updated: October 31, 2011
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013