Surgical Treatment of Mild Obstructive Sleep Apnea

Kuopio University Hospital

Status: Unknown

Conditions: Sleep Apnea

Treatments: Other: Lifestyle counselling by physician; Procedure: Modified tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00747890

KUH5551817

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

I

Active Comparator group

Treatment:

Procedure: Modified tonsillectomy

II

Other group

Treatment:

Other: Lifestyle counselling by physician