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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00747890
Other study ID # KUH5551817
Secondary ID
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


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
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