Clinical trial NCT01659671: RCT of the Effect of Uvulopalatopharyngoplasty Compared to Expectancy in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2012-08-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis:Pharyngeal surgery (UPPP) reduces significantly the nightly respiratory breathing pauses (apnoeas-hypopnoeas) and improves the daytime symptoms compared to expectancy for 6 months in patients with OSAS.

Background: Obstructive sleep apnea syndrome (OSAS) is associated with an increased risk of poor sleep quality, excessive daytime sleepiness and prolonged reaction time, which can elevate the risk for traffic accidents. Increased morbidity and three to four times increased mortality in these patients are well documented, mainly in the cardiovascular field. Pharyngeal surgery, i.e. uvulopalatopharyngoplasty (UPPP) opens up the airway and was the predominant treatment for OSAS worldwide before continuous positive airway pressure (CPAP) devices became widely available in the 1990s. Since then, the main treatment for OSAS has been CPAP, but an increasing number of patients are also treated with mandibular retaining device (MRD). UPPP as treatment for OSAS has been performed for 30 years. The evidence-grade for the efficacy has so far been very low, and the side-effects and complication rate has raised the question whether there is a place for surgical treatment of OSAS. However, the compliance for CPAP and dental devices are quite low (50-60%), leaving a lot of patients untreated if surgery is not offered. RCT UPPP is still missing and called for.


Eligibility criteria: Inclusion Criteria:

ApnéHypopnéIndex, AHI \>14,9 Daytime sleepiness w Epworth sleepiness scale, ESS\> 7 Sleepy during daytime 3-5 times per week or more BodyMassIndex, BMI \< 36,0 Friedman staging system of tonsil size and tongue: i and II Patients w Friedman stage I and BMI \< 30,0 could be directly included if patient positive and no contra-indications for surgery. All others should be failure of CPAP and MRD before inclusion.

Exclusion Criteria:

Other OSAS treatment during study, i.e., patient is clinically severely deteriorated.

Negative to surgery Night-shift worker Friedman stage III or IV Morbid obesity BMI \>35,9 Severe psychological or neurological disease ASA class \>3 Severe lung- or heart disease (not applicable for hypertension, nor stroke or MI more than after 2 years).

Insufficient knowledge in Swedish language (important for filling in questionnaires) Dangerous in traffic while driving Severe nasal congestion (can be included after successful treatment) Previous tonsillectomy

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Primary outcomes:
measure: Changes in apnea-hypopnea index
timeFrame: 6 months and 2 years
Secondary outcomes:
measure: Changes in Epworth sleepiness scale
timeFrame: 6 months and 2 years
Other outcomes:
measure: Changes in Oxygen desaturation index
timeFrame: 6 months and 2 years
measure: changes in blood samples
timeFrame: 6 months 2 years
measure: changes in score of SF 36 quality of life questionnaire
timeFrame: 6 months and 2 years
measure: changes in blood pressure
timeFrame: 6 months and 2 years
measure: changes in vigilance
timeFrame: 6 months and 2 years
measure: number of patients with serious complications from surgery
timeFrame: 6 months
measure: number of patients with side-effects from surgery
timeFrame: 6 months and 2 years
measure: Changes in score of FOSQ questionnaire
timeFrame: 6 months and 2 years
measure: identifying success factors for outcome of surgical intervention
timeFrame: 6 months 2 years
measure: changes in arousal index
timeFrame: 6 months and 2 years
measure: changes in lowest oxygen saturation during sleep
timeFrame: 6 months 2 years
measure: changes in ODI during REM sleep
timeFrame: 6 months 2 years
measure: changes in ODI in supine position
timeFrame: 6 months 2 years
measure: changes in time in supine position
timeFrame: 6 months and 2 years
measure: changes in Body Mass Index
timeFrame: 6 months and 2 years
measure: changes in RERA index
timeFrame: 6 months and 2 years
measure: changes in mean length apneas and hypopneas
timeFrame: 6 months and 2 years
measure: changes in AHI supine position
timeFrame: 6 months 2 years
measure: changes in AHI in REM
timeFrame: 6 months and 2 years
measure: changes in total sleep time
timeFrame: 6 months and 2 years
measure: changes in RDI
timeFrame: 6 months and 2 years
Locations:
city: Stockholm
country: Sweden
facility: ORL dep, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital, Karolinska Institutet
name: Danielle K Friberg, MD, PhD, Associate professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joar S, Danielle F, Johan B, Arne L, Roberta N, Nanna B. Sleep Quality After Modified Uvulopalatopharyngoplasty: Results From the SKUP3 Randomized Controlled Trial. Sleep. 2018 Jan 1;41(1). doi: 10.1093/sleep/zsx180.
citation: Fehrm J, Friberg D, Bring J, Browaldh N. Blood pressure after modified uvulopalatopharyngoplasty: results from the SKUP3 randomized controlled trial. Sleep Med. 2017 Jun;34:156-161. doi: 10.1016/j.sleep.2017.02.030. Epub 2017 Apr 4.
citation: Browaldh N, Bring J, Friberg D. SKUP(3) RCT; continuous study: Changes in sleepiness and quality of life after modified UPPP. Laryngoscope. 2016 Jun;126(6):1484-91. doi: 10.1002/lary.25642. Epub 2015 Sep 25.
citation: Browaldh N, Nerfeldt P, Lysdahl M, Bring J, Friberg D. SKUP3 randomised controlled trial: polysomnographic results after uvulopalatopharyngoplasty in selected patients with obstructive sleep apnoea. Thorax. 2013 Sep;68(9):846-53. doi: 10.1136/thoraxjnl-2012-202610. Epub 2013 May 5.