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Surgical Treatment of Mild Obstructive Sleep Apnea

Primary Purpose

Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Modified tonsillectomy
Lifestyle counselling by physician
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Apnea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kuopio University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

I

II

Arm Description

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index

Secondary Outcome Measures

Quality of life

Full Information

First Posted
September 4, 2008
Last Updated
October 31, 2011
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00747890
Brief Title
Surgical Treatment of Mild Obstructive Sleep Apnea
Official Title
The Effects of Surgical Treatment on Mild Obstructive Sleep Apnea and Its Co-morbidities
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Title
II
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Modified tonsillectomy
Intervention Description
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
Other
Intervention Name(s)
Lifestyle counselling by physician
Intervention Description
General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance.
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index
Time Frame
One year(before and after surgery)
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henry Blomster, MD
Phone
+358447172513
Email
henry.blomster@kuh.fi
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70300
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry Blomster, MD
Email
henry.blomster@kuh.fi

12. IPD Sharing Statement

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Surgical Treatment of Mild Obstructive Sleep Apnea

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