Surgical Treatment of Mild Obstructive Sleep Apnea

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00747890

Enrollment

100

Registered

2008-09-05

Start date

2008-09-30

Completion date

2012-12-31

Last updated

2011-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Brief 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.

Interventions

PROCEDUREModified 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

OTHERLifestyle counselling by physician

General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Apnea Hypopnea Index	One year(before and after surgery)

Secondary

Measure	Time frame
Quality of life	One Year

Countries

Finland

Contacts

Primary ContactHenry Blomster, MD

henry.blomster@kuh.fi+358447172513

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026