Tonsillar HypertrophyNCT04314492
Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
A study testing Tonsillectomy in people with Tonsillar Hypertrophy and Sleep Apnea, Obstructive, run by Turku University Hospital at 2 sites in Finland.
Trial summary
Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Tonsillar Hypertrophy, Sleep Apnea, Obstructive
- What is being tested?
- Tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Sep 2020to 31 Jan 2025
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 16-64
- Planned tonsil surgery with informed concent
- Obstructive sleep apnea (AHI > 15)
- Tonsillar size of 3-4 on the Friedman scale
Who cannot join
- BMI > 35 (Based on finnish Käypä Hoito -recommendations)
- Central sleep apnea
- Weight loss of more than 10% within the study period
- Untreated obstruction of nasal breathing
- Treated peritonsillar abscess <1 month before enrollment
- Active tonsillar infection
Show all 14Show fewer
- Previous tonsillar surgery (excluding incision of abscess)
- Malignancy
- High use of analgesics >1 DDD daily during last 4 weeks
- Untreated reflux
- Anticoagulative medication
- Any condition of hemophilia
- Pregnancy, lactation
- Other, evaluated by treating physician
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Satasairaala
Pori, Satakunta, 28500
Turku University Hospital
Turku, Southwest Finland, 20521
About this study
Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation
Read the detailed description
The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.
- Conditions
- Tonsillar Hypertrophy, Sleep Apnea, Obstructive
- Being tested
- Tonsillectomy
- Keywords
- tonsil surgery, tonsillectomy, obstructive sleep apnea, coblation, intracapsular
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonsillectomyProcedure or surgery
Intracapsular removal of tonsillar tissue (>90%) with coblation
| Study group | Role | What they receive |
|---|---|---|
| Intracapsular tonsillectomy with coblation | Experimental | (Total) Intracapsular tonsillectomy (ICTE) with coblation Receives: Procedure: Tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index
Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.
Measured: 6 months
Secondary outcomes (8)
Quality of life measured by Glasgow Benefit Inventory
General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.
Measured: 6 months and 24 month and 60 months
Quality of life measured by Nordic tonsil surgery register questionnaire
Questions regarding postoperative complications and perceived symptom relief after 180 days. Yes/no questions and open questions, no score.
Measured: 6 months - up to 5 years
Quality of life measured by Epworth sleepiness scale
Questions regarding sleepiness. Score 0-24, lower is better.
Measured: 6 months - up to 5 years
Post-operative recovery
Recovery speed defined as score 3 or less at rest; or 5 or less without regular analgesics use, questionnaire used: Brief Pain Inventory.
Measured: 21 days
Total recovery of obstructive sleep apnea
Defined by apnea-hypopnea index <5 post-operatively in polysomnography.
Measured: 6 months and 24 months and 60 months
Regrowth of tonsillar tissue
Measured by photography, Friedman scale (0-4, lower is smaller).
Measured: Pre-operative to 6 months
Apnea-index
Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography.
Measured: 6 months and 24 months and 60 months
Snoring time
Post-operative reduction of snoring time in preoperative polysomnography compared to post-operative values in
Measured: 6 months and 24 months and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Sep 2020
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsillar HypertrophyStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jaakko Piitulainen, Turku University Hospital
- Investigators
- Jussi Jero, Professor, Study director, University of TurkuJaakko Piitulainen, M.D., Ph.D., Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314492
- Sponsor's protocol ID
- T62/2020
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2020
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
- ClinicalTrials.gov ID
- NCT04314492
- Acronym / sponsor ID
- T62/2020
- Conditions
- Tonsillar Hypertrophy, Sleep Apnea, Obstructive
- Keywords
- tonsil surgery, tonsillectomy, obstructive sleep apnea, coblation, intracapsular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 19 Mar 2020 (actual)
- 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.
Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation
Detailed description
The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracapsular tonsillectomy with coblation | Experimental | Procedure: Tonsillectomy(Total) Intracapsular tonsillectomy (ICTE) with coblation |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age 16-64
- Planned tonsil surgery with informed concent
- Obstructive sleep apnea (AHI > 15)
- Tonsillar size of 3-4 on the Friedman scale
Key exclusion criteria (14 listed)
- BMI > 35 (Based on finnish Käypä Hoito -recommendations)
- Central sleep apnea
- Weight loss of more than 10% within the study period
- Untreated obstruction of nasal breathing
- Treated peritonsillar abscess <1 month before enrollment
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 |
|---|---|---|
| TonsillectomyIntracapsular removal of tonsillar tissue (>90%) with coblation | Procedure or surgery | Intracapsular tonsillectomy with coblation |
Primary outcome
Apnea-hypopnea index
Time frame: 6 months
Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.
8 secondary outcomes
Quality of life measured by Glasgow Benefit Inventory
Time frame: 6 months and 24 month and 60 months
Quality of life measured by Nordic tonsil surgery register questionnaire
Time frame: 6 months - up to 5 years
Quality of life measured by Epworth sleepiness scale
Time frame: 6 months - up to 5 years
Post-operative recovery
Time frame: 21 days
Total recovery of obstructive sleep apnea
Time frame: 6 months and 24 months and 60 months
Regrowth of tonsillar tissue
Time frame: Pre-operative to 6 months
Apnea-index
Time frame: 6 months and 24 months and 60 months
Snoring time
Time frame: 6 months and 24 months and 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Tonsillar Hypertrophy
Recruiting
Photobiomodulation for Pediatric Hypertrophic Tonsils
Pediatric Sleep Apnea, Obstructive Sleep Apnea
Not yet recruiting
Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery
Adenoid Hypertrophy, Tonsillar Hypertrophy
Not yet recruiting
Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils
Sleep Apnea, Obstructives, Tonsil Hypertrophy
Recruiting
Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children
Not yet recruitingObservational study
Evaluation of the Effects of Adenoidectomy and Adenotonsillectomy on Voice in Children
Adenoid Hypertrophy, Tonsillar Hypertrophy
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.
Jussi Jero, Professor study director
University of Turku
Jaakko Piitulainen, M.D., Ph.D. principal investigator
Turku University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonsillectomy in people with Tonsillar Hypertrophy and Sleep Apnea, Obstructive, run by Turku University Hospital at 2 sites 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 14 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: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2025.