Obstructive Sleep ApneaNCT05049369
Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
A study testing Polysomnography in people with Obstructive Sleep Apnea and Tonsillar Hypertrophy, run by Turku University Hospital at 1 site in Finland.
Trial summary
Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Tonsillar Hypertrophy, Sleep Apnea Syndromes
- What is being tested?
- Polysomnography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFinland
- Study dates
- 25 Jan 2022to 4 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age at least 16 during tonsillectomy
- preoperative obstructive sleep apnea and AHI (apnea-hypopnea index) > 14
- tonsillectomy has been done because of the symptoms caused by tonsillar hypertrophy (ICD-10 diagnostic codes G47.3, R06.5 or J35.1)
- in addition to tonsillectomy, patients may have undergone shortening of uvula and/or radio frequency ablation of soft palate
Who cannot join
- AHI < 14
- in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement
- other, evaluated by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults
Read the detailed description
The investigators are studying long-term efficiency of tonsillectomy in adults with obstructive sleep apnea caused by tonsillar hypertrophy. These patients have undergone tonsillectomy in 2004-2018 and now 3-17 years later investigators will perform new polysomnographies and compare these results with preoperative values. Especially the reduction in apnea-hypopnea index (AHI) will be evaluated. The quality of life and possible symptoms will be measured with questionnaires.
- Being tested
- Polysomnography
- Keywords
- tonsillectomy, obstructive sleep apnea, tonsil surgery
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDevice
Polysomnography is performed one time overnight
| Study group | Role | What they receive |
|---|---|---|
| Polysomnography for all participants of the study | Experimental | Polysomnography device is used to measure certain variables overnight when a participant is sleeping Receives: Device: Polysomnography |
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 (AHI) reduction by 50% compared to preoperative values in polysomnography.
Measured: 3-17 years
Secondary outcomes (5)
Quality of life measured by Glasgow Benefit Inventory (GBI)
General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.
Measured: 3-17 years
Quality of life measured by Epworth sleepiness scale (ESS)
Questions regarding sleepiness. Score 0-24, lower is better.
Measured: 3-17 years
Apnea-index (AI)
Post-operative apnea index reduction compared to preoperative values in polysomnography.
Measured: 3-17 years
Snoring time
Post-operative reduction of snoring time compared to preoperative values in polysomnography
Measured: 3-17 years
Oxygen Desaturation Index (ODI)
Post-operative reduction of oxygen desaturation index compared to preoperative values in polysomnography
Measured: 3-17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start25 Jan 2022
- Primary completion1 Oct 2022
- Study completion4 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jaakko M Piitulainen, MD,PhD, Principal investigator, Department of Otorhinolaryngology, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049369
- Sponsor's protocol ID
- T205/2021
- Status last verified
- Dec 2023
- First submitted
- 10 Sep 2021
- Last updated
- 26 Dec 2023
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
- ClinicalTrials.gov ID
- NCT05049369
- Acronym / sponsor ID
- T205/2021
- Keywords
- tonsillectomy, obstructive sleep apnea, tonsil surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 4 Dec 2022 (actual)
- First posted
- 20 Sep 2021 (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.
Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults
Detailed description
The investigators are studying long-term efficiency of tonsillectomy in adults with obstructive sleep apnea caused by tonsillar hypertrophy. These patients have undergone tonsillectomy in 2004-2018 and now 3-17 years later investigators will perform new polysomnographies and compare these results with preoperative values. Especially the reduction in apnea-hypopnea index (AHI) will be evaluated. The quality of life and possible symptoms will be measured with questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polysomnography for all participants of the study | Experimental | Device: PolysomnographyPolysomnography device is used to measure certain variables overnight when a participant is sleeping |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age at least 16 during tonsillectomy
- preoperative obstructive sleep apnea and AHI (apnea-hypopnea index) > 14
- tonsillectomy has been done because of the symptoms caused by tonsillar hypertrophy (ICD-10 diagnostic codes G47.3, R06.5 or J35.1)
- in addition to tonsillectomy, patients may have undergone shortening of uvula and/or radio frequency ablation of soft palate
Key exclusion criteria (3 listed)
- AHI < 14
- in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement
- other, evaluated by investigator
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 |
|---|---|---|
| PolysomnographyPolysomnography is performed one time overnight | Device | Polysomnography for all participants of the study |
Primary outcome
Apnea-hypopnea index
Time frame: 3-17 years
Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography.
5 secondary outcomes
Quality of life measured by Glasgow Benefit Inventory (GBI)
Time frame: 3-17 years
Quality of life measured by Epworth sleepiness scale (ESS)
Time frame: 3-17 years
Apnea-index (AI)
Time frame: 3-17 years
Snoring time
Time frame: 3-17 years
Oxygen Desaturation Index (ODI)
Time frame: 3-17 years
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 26 Dec 2023.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Jaakko M Piitulainen, MD,PhD principal investigator
Department of Otorhinolaryngology, Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography in people with Obstructive Sleep Apnea and Tonsillar Hypertrophy, run by Turku 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 3 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 26 Dec 2023. 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?
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: 3-17 years). 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 26 Dec 2023.