RCT of the Effect of Uvulopalatopharyngoplasty Compared to Expectancy in Patients With Obstructive Sleep Apnea

Obstructive Sleep Apnea Syndrome Clinical Trial

— SKUP3  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659671
• Other study ID #: 2007/449-31/3, Ö 21-2007
• Secondary ID: 2007/449-31/3, Ö
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: December 12, 2014
• Start date: June 2007
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Uvulopalatopharyngoplasty
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.

Locations

Country	Name	City	State
Sweden	ORL dep, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Oxygen desaturation index	Oxygen desaturation index (ODI) is the number of oxygen desaturations of 3 % or more per sleep hour.	6 months and 2 years	No
Other	changes in blood samples	Hb, LPK, CRP, cortisol, TSH, T4, ASAT, ALAT, ALP, ?-GT, CDT, Leptin/ghrelin, fB-Glucose, f-insulin, HDL, LDL, Cholesterol, Triglycerides, TNF-a, IL-1, IL-6	6 months 2 years	No
Other	changes in score of SF 36 quality of life questionnaire	QoL SF 36 validated questionnaire	6 months and 2 years	No
Other	changes in blood pressure	systolic and diastolic morning pressure from arm	6 months and 2 years	No
Other	changes in vigilance	modified Osler test	6 months and 2 years	No
Other	number of patients with serious complications from surgery		6 months	Yes
Other	number of patients with side-effects from surgery	answers from a local questionnaire regaring pharyngeal side-effects	6 months and 2 years	No
Other	Changes in score of FOSQ questionnaire	Validated questionnaire designed for patients with obstructive sleep apnea syndrome	6 months and 2 years	No
Other	identifying success factors for outcome of surgical intervention	Correlate for example tonsil size and tongue position (stageing system) with changes in AHI	6 months 2 years	No
Other	changes in arousal index	Polysomnographic results	6 months and 2 years	No
Other	changes in lowest oxygen saturation during sleep	Polysomnographic results	6 months 2 years	No
Other	changes in ODI during REM sleep	Polysomnographic results	6 months 2 years	No
Other	changes in ODI in supine position	Polysomnographic results	6 months 2 years	No
Other	changes in time in supine position	Polysomnographic results	6 months and 2 years	No
Other	changes in Body Mass Index		6 months and 2 years	No
Other	changes in RERA index	Polysomnographic results, RERA are the respiratory effort related arousals during sleep	6 months and 2 years	No
Other	changes in mean length apneas and hypopneas	Polysomnographic results	6 months and 2 years	No
Other	changes in AHI supine position	Polysomnographic results	6 months 2 years	No
Other	changes in AHI in REM	Polysomnographic results	6 months and 2 years	No
Other	changes in total sleep time	Polysomnograåhic results	6 months and 2 years	No
Other	changes in RDI	Polysomnographic results; RDI is the sum of AHI and RERA index	6 months and 2 years	No
Primary	Changes in apnea-hypopnea index	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	6 months and 2 years	No
Secondary	Changes in Epworth sleepiness scale	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.	6 months and 2 years	No