Sleep ApneaNCT00747890
Surgical Treatment of Mild Obstructive Sleep Apnea
A study testing Modified tonsillectomy and Lifestyle counselling by physician in people with Sleep Apnea, run by Kuopio University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Modified tonsillectomy and Lifestyle counselling by physician
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- BMI <35
- AHI 5-30 events/h
- Largened tonsils Grade ≥1
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, 70300
Henry Blomster, MD, henry.blomster@kuh.fi
About this study
Official title: The Effects of Surgical Treatment on Mild Obstructive Sleep Apnea and Its Co-morbidities
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.
- Conditions
- Sleep Apnea
- Being tested
- Modified tonsillectomy, Lifestyle counselling by physician
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified tonsillectomyProcedure or surgery
- Tonsillectomy
- Uvulectomy
- Soft palatal resection
- Lifestyle counselling by physician: General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance
Lifestyle counselling by physicianOther
General (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance.
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Not described Receives: Procedure: Modified tonsillectomy |
| II | Other | Not described Receives: Other: Lifestyle counselling by physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index
Measured: One year(before and after surgery)
Secondary outcomes (1)
Quality of life
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Blomster, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747890
- Sponsor's protocol ID
- KUH5551817
- Status last verified
- Oct 2011
- First submitted
- 4 Sep 2008
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40957567
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Surgical Treatment on Mild Obstructive Sleep Apnea and Its Co-morbidities
- ClinicalTrials.gov ID
- NCT00747890
- Acronym / sponsor ID
- KUH5551817
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Procedure: Modified tonsillectomy |
| II | Other | Other: Lifestyle counselling by physician |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65
- BMI <35
- AHI 5-30 events/h
- Largened tonsils Grade ≥1
Key exclusion criteria (8 listed)
- Age <18 or > 65
- BMI >35
- AHI <5 or >30
- Tonsil size < 1
- Severe nasal polyposis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | I |
| Lifestyle counselling by physicianGeneral (e.g. avoidance of smoking, alcohol drinking) and nutritional education, and sleeping positional guidance. | Other | II |
Primary outcome
Apnea Hypopnea Index
Time frame: One year(before and after surgery)
1 secondary outcome
Quality of life
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
- Derived from this study: PubMed 40957567Makkonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified tonsillectomy and Lifestyle counselling by physician in people with Sleep Apnea, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henry Blomster, MD (+358447172513, henry.blomster@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (time frame: One year(before and after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00747890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2011.