Surgical Treatment of Mild Obstructive Sleep Apnea

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00747890
• Other study ID #: KUH5551817
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2008
• Last updated: October 31, 2011
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: October 2011
• Source: Kuopio University Hospital
• Contact: Henry Blomster, MD
• Phone: +358447172513
• Email: henry.blomster[@]kuh.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

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

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index		One year(before and after surgery)	No
Secondary	Quality of life		One Year	No