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Surgical Treatment of Mild Obstructive Sleep Apnea

NCT ID: NCT00747890

Last Updated: 2011-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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I

Group Type ACTIVE_COMPARATOR

Modified tonsillectomy

Intervention Type PROCEDURE

* 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

Group Type OTHER

Lifestyle counselling by physician

Intervention Type OTHER

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

Interventions

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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

Intervention Type PROCEDURE

Lifestyle counselling by physician

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Henry Blomster

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Henry Blomster, MD

Role: CONTACT

[email protected]
+358447172513

Facility Contacts

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Henry Blomster, MD

Role: primary

[email protected]

References

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Makkonen J, Blomster H, Raappana A, Markkanen S, Numminen J, Kivekas I, Valtonen O, Rautiainen M, Tuomilehto H. Adult obstructive sleep apnea treated with tonsillectomy: a randomized controlled clinical trial. Acta Otolaryngol. 2025 Oct;145(10):989-996. doi: 10.1080/00016489.2025.2557566. Epub 2025 Sep 16.

Reference Type DERIVED
PMID: 40957567 (View on PubMed)

Other Identifiers

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KUH5551817

Identifier Type: -

Identifier Source: org_study_id