ORL dep, Karolinska University Hospital
Stockholm, 141 86, Sweden
NCT Number: NCT01659671
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Stockholm, 141 86, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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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Uvulopalatopharyngoplasty: Resection of the soft palate 3 mm and tonsillectomy, amputation of the uvula to approx 1 cm, single sutures of the posterior pillar to the anterior pillar and of the soft palate.
Time frame: 6 months and 2 years
Apnea-hypopnea index (AHI) is the number of apneas or hypopneas per sleep hour. Polysomnography (PSG) is the Golden standard to use when measuring the AHI. PSG is the method we are using
Time frame: 6 months and 2 years
Epworth sleepiness scale is a validated questionnaire. It consists of eight questions concerning the patients´ ability to fall asleep in different situations. The total sum is 24.
Time frame: 6 months and 2 years
Oxygen desaturation index (ODI) is the number of oxygen desaturations of 3 % or more per sleep hour.
Time frame: 6 months 2 years
Hb, LPK, CRP, cortisol, TSH, T4, ASAT, ALAT, ALP, γ-GT, CDT, Leptin/ghrelin, fB-Glucose, f-insulin, HDL, LDL, Cholesterol, Triglycerides, TNF-α, IL-1, IL-6
Time frame: 6 months and 2 years
QoL SF 36 validated questionnaire
Time frame: 6 months and 2 years
systolic and diastolic morning pressure from arm
Time frame: 6 months and 2 years
modified Osler test
Time frame: 6 months
Time frame: 6 months and 2 years
answers from a local questionnaire regaring pharyngeal side-effects
Time frame: 6 months and 2 years
Validated questionnaire designed for patients with obstructive sleep apnea syndrome
Time frame: 6 months 2 years
Correlate for example tonsil size and tongue position (stageing system) with changes in AHI
Time frame: 6 months and 2 years
Polysomnographic results
Time frame: 6 months 2 years
Polysomnographic results
Time frame: 6 months 2 years
Polysomnographic results
Time frame: 6 months 2 years
Polysomnographic results
Time frame: 6 months and 2 years
Polysomnographic results
Time frame: 6 months and 2 years
Time frame: 6 months and 2 years
Polysomnographic results, RERA are the respiratory effort related arousals during sleep
Time frame: 6 months and 2 years
Polysomnographic results
Time frame: 6 months 2 years
Polysomnographic results
Time frame: 6 months and 2 years
Polysomnographic results
Time frame: 6 months and 2 years
Polysomnograåhic results
Time frame: 6 months and 2 years
Polysomnographic results; RDI is the sum of AHI and RERA index
Karolinska University Hospital
Other
Acronym: SKUP3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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