Obstructive Sleep ApneaNCT02523248
Comparison Between UPPP and Tonsillectomy in Adult OSA
A study testing tonsillectomy and Uvulopalatopharyngoplasty in people with Obstructive Sleep Apnea, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The aim of this randomized control study is to evaluate the effect of tonsillectomy with or without uvulopalatoplasty in treating adults with moderate to severe sleep apnea. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- tonsillectomy and Uvulopalatopharyngoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2016to Jan 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI more than 15
- Friedmans stage I and II
- Tonsil size 2, 3 and 4
- BMI below 34
- Failed use of CPAP and dental device
Who cannot join
- Severe cardiovascular or neurological disease
- Prefers strongly one surgical method
- ASA IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Study Between Uvulopalatopharyngoplasty and Tonsillectomy in Adult Sleep Apnea Patients
The aim of this randomized control study is to evaluate the effect of tonsillectomy with or without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.
Read the detailed description
Patients are after baseline PSG 1 included and randomized to either UPPP or TE. They are stratified according to tonsil size, those with size 2 in one group and those with 3-4 in another. They all undergo surgery within two months and thereafter PSG 2 after 6 months and PSG after 4 years. At PSG they fill in questionnaires and measurements of blood pressure.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- tonsillectomy, Uvulopalatopharyngoplasty
- 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
Tonsillectomy with cold steel
UvulopalatopharyngoplastyProcedure or surgery
Also called UPPP
Tonsillectomy and uvulopalatoplasty with cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle
| Study group | Role | What they receive |
|---|---|---|
| Tonsillectomy | Active comparator | Tonsillectomy with cold steel Receives: Procedure: tonsillectomy |
| Uvulopalatopharyngoplasty | Active comparator | Tonsillectomy and uvulopalatoplasty; using cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle Receives: Procedure: Uvulopalatopharyngoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
measurements with inlab polysomnography
Measured: 6 months
Secondary outcomes (3)
Questionnaire: group differences of changes in daytime sleepiness
A validated questionnaire: Epworth sleepiness scale
Measured: 6 months
Questionnaire: group differences in changes of general health
A validated question of self-reported health
Measured: 6 months
Group differences in changes of blood pressure
Measurements of blood pressure the morning after inlab polysomnography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJan 2016
- Primary completionNov 2021
- Study completionJan 2022
Why it stopped: Because of Covid 19 pandemic situation delay in recruiting patients
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 Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Karolinska 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Friberg, Karolinska University Hospital
- Investigators
- Bo Tideholm, MD, PhD, Study director, Karolinska University Hospital, ORL dep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523248
- Sponsor's protocol ID
- 2015/755-31/2
- Status last verified
- Mar 2022
- First submitted
- 6 Aug 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Sundman J, Nerfeldt P, Fehrm J, Bring J, Browaldh N, Friberg D. Effectiveness of Tonsillectomy vs Modified Uvulopalatopharyngoplasty in Patients With Tonsillar Hypertrophy and Obstructive Sleep Apnea: The TEAMUP Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Dec 1;148(12):1173-1181. doi: 10.1001/jamaoto.2022.3432.
PubMed 36326742
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Study Between Uvulopalatopharyngoplasty and Tonsillectomy in Adult Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT02523248
- Acronym / sponsor ID
- 2015/755-31/2
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of Covid 19 pandemic situation delay in recruiting patients
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 14 Aug 2015 (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.
The aim of this randomized control study is to evaluate the effect of tonsillectomy with or without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.
Detailed description
Patients are after baseline PSG 1 included and randomized to either UPPP or TE. They are stratified according to tonsil size, those with size 2 in one group and those with 3-4 in another. They all undergo surgery within two months and thereafter PSG 2 after 6 months and PSG after 4 years. At PSG they fill in questionnaires and measurements of blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tonsillectomy | Active comparator | Procedure: tonsillectomyTonsillectomy with cold steel |
| Uvulopalatopharyngoplasty | Active comparator | Procedure: UvulopalatopharyngoplastyTonsillectomy and uvulopalatoplasty; using cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AHI more than 15
- Friedmans stage I and II
- Tonsil size 2, 3 and 4
- BMI below 34
- Failed use of CPAP and dental device
Key exclusion criteria (3 listed)
- Severe cardiovascular or neurological disease
- Prefers strongly one surgical method
- ASA IV
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 |
|---|---|---|
| tonsillectomyTonsillectomy with cold steel | Procedure or surgery | Tonsillectomy |
| UvulopalatopharyngoplastyAlso: UPPPTonsillectomy and uvulopalatoplasty with cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle | Procedure or surgery | Uvulopalatopharyngoplasty |
Primary outcome
Polysomnography: group differences of changes in apnea-hypopnea index (AHI)
Time frame: 6 months
measurements with inlab polysomnography
3 secondary outcomes
Questionnaire: group differences of changes in daytime sleepiness
Time frame: 6 months
Questionnaire: group differences in changes of general health
Time frame: 6 months
Group differences in changes of blood pressure
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Because of Covid 19 pandemic situation delay in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 36326742Sundman J, Nerfeldt P, Fehrm J, Bring J, Browaldh N, Friberg D. Effectiveness of Tonsillectomy vs Modified Uvulopalatopharyngoplasty in Patients With Tonsillar Hypertrophy and Obstructive Sleep Apnea: The TEAMUP Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Dec 1;148(12):1173-1181. doi: 10.1001/jamaoto.2022.3432.
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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.
Bo Tideholm, MD, PhD study director
Karolinska University Hospital, ORL dep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tonsillectomy and Uvulopalatopharyngoplasty in people with Obstructive Sleep Apnea, run by Karolinska University Hospital at 1 site in Sweden.
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 5 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: stopped early, as of the sponsor's last update on 31 Mar 2022. 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 Sweden. 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 was stopped early (reason given: Because of Covid 19 pandemic situation delay in recruiting patients). Results are not available in the source record.
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?
Polysomnography: group differences of changes in apnea-hypopnea index (AHI) (time frame: 6 months). 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 NCT02523248, 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 31 Mar 2022.