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Because of Covid 19 pandemic situation delay in recruiting patients
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tonsillectomy | Active Comparator | Tonsillectomy with cold steel |
|
| Uvulopalatopharyngoplasty | Active Comparator | Tonsillectomy and uvulopalatoplasty; using cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tonsillectomy | Procedure | Tonsillectomy with cold steel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography: group differences of changes in apnea-hypopnea index (AHI) | measurements with inlab polysomnography | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire: group differences of changes in daytime sleepiness | A validated questionnaire: Epworth sleepiness scale | 6 months |
| Questionnaire: group differences in changes of general health | A validated question of self-reported health |
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography: group differences of changes in apnea-hypopnea index (AHI) | measurements with inlab polysomnography | 4 years |
| Questionnaire: group differences of changes in daytime sleepiness | A validated questionnaire: Epworth sleepiness scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Tideholm, MD, PhD | Karolinska University Hospital, ORL dep | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orl dep, Karolinska University Hospital | Stockholm | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36326742 | Derived | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Uvulopalatopharyngoplasty |
| Procedure |
Tonsillectomy and uvulopalatoplasty with cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle |
|
|
| 6 months |
| Group differences in changes of blood pressure | Measurements of blood pressure the morning after inlab polysomnography | 6 months |
| 4 years |
| Questionnaire: group differences in changes of general health | A validated question of self-reported health | 4 years |
| Questionnaire of pharyngeal side-effects pre-and postoperatively | Questionnaire with 10 questions of pharyngeal disturbances administrated before and 6 months after surgery | 6 months |
| Postoperative bleeding complications | Patient charts how many days patients stayed at hospitals postoperatively, reoperations and medications | 6 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |