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SKUP(3) RCT; continuous study: Changes in sleepiness and quality of life after modified UPPP
Nanna Browaldh1, Johan Bring2, Danielle Friberg1
1Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, and Department of ORL Diseases, Karolinska University Hospital, Stockholm.
Objectives/Hypothesis:
Our previous study showed that modified uvulopalatopharyngoplasty (UPPP), including tonsillectomy, significantly improved nocturnal respiration in obstructive sleep apnea syndrome (OSAS) patients. This is a continuous study of changes in daytime sleepiness and quality of life.
Study Design:
Prospective randomized controlled trial (RCT), two parallel arms.
Methods:
Sixty-five patients with apnea-hypopnea index ≥ 15, body mass index < 36, Epworth Sleepiness Scale (ESS) ≥ 8, Friedman stage I or II, failing nonsurgical treatment. The intervention group (n = 32) underwent surgery, and the controls (n = 33) had no treatment. At baseline and the 7-month follow-up, polysomnography, questionnaires, and vigilance tests were implemented.
Results:
All patients answered the questionnaires, and 48 took the vigilance test. Epworth Sleepiness Scale decreased significantly in the intervention group, from a mean (standard deviation) of 12.5(3.2) to 6.8(3.9), but nonsignificantly in the control group, from 12.9(3.1) to 12.5(3.9), a significant group difference (P < 0.001). The physical and mental component score on the Short Form-36 questionnaire increased significantly in the intervention group, from a mean 47.8(8.3) to 51.2(8.8) and from 42.1(10.6) to 48.1(9.7), respectively, but with nonsignificant changes in the controls: 49.0(9.0) to 48.3(9.1) and 41.0(10.2) to 42.7(11.5), significant group differences (P = 0.007, P = 0.031), respectively. The sleep latency/vigilance test showed a significant mean increase in the intervention group of 7(12.4) minutes and a decrease in the controls of 2.2(10.6), a significant group difference (P = 0.011). There were significant correlations between changes in subjective outcomes and nocturnal respiration.
Conclusion:
This RCT shows that modified UPPP was effective in improving daytime sleepiness and quality of life in OSAS patients. It strengthens the body of evidence on the potential effect of surgery offered to selected patients.
Level Of Evidence:
1b. Laryngoscope, 126:1484-1491, 2016.
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