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Completed

NCT Number: NCT01659671

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ORL dep, Karolinska University Hospital

Stockholm, 141 86, Sweden

Who can participate

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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Treatment and study plan

Uvulopalatopharyngoplasty

Procedure

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.

Primary outcomes

  1. Changes in apnea-hypopnea index

    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

Secondary outcomes

  1. Changes in Epworth sleepiness scale

    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.

Other outcomes

  1. Changes in Oxygen desaturation index

    Time frame: 6 months and 2 years

    Oxygen desaturation index (ODI) is the number of oxygen desaturations of 3 % or more per sleep hour.

  2. changes in blood samples

    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

  3. changes in score of SF 36 quality of life questionnaire

    Time frame: 6 months and 2 years

    QoL SF 36 validated questionnaire

  4. changes in blood pressure

    Time frame: 6 months and 2 years

    systolic and diastolic morning pressure from arm

  5. changes in vigilance

    Time frame: 6 months and 2 years

    modified Osler test

  6. number of patients with serious complications from surgery

    Time frame: 6 months

  7. number of patients with side-effects from surgery

    Time frame: 6 months and 2 years

    answers from a local questionnaire regaring pharyngeal side-effects

  8. Changes in score of FOSQ questionnaire

    Time frame: 6 months and 2 years

    Validated questionnaire designed for patients with obstructive sleep apnea syndrome

  9. identifying success factors for outcome of surgical intervention

    Time frame: 6 months 2 years

    Correlate for example tonsil size and tongue position (stageing system) with changes in AHI

  10. changes in arousal index

    Time frame: 6 months and 2 years

    Polysomnographic results

  11. changes in lowest oxygen saturation during sleep

    Time frame: 6 months 2 years

    Polysomnographic results

  12. changes in ODI during REM sleep

    Time frame: 6 months 2 years

    Polysomnographic results

  13. changes in ODI in supine position

    Time frame: 6 months 2 years

    Polysomnographic results

  14. changes in time in supine position

    Time frame: 6 months and 2 years

    Polysomnographic results

  15. changes in Body Mass Index

    Time frame: 6 months and 2 years

  16. changes in RERA index

    Time frame: 6 months and 2 years

    Polysomnographic results, RERA are the respiratory effort related arousals during sleep

  17. changes in mean length apneas and hypopneas

    Time frame: 6 months and 2 years

    Polysomnographic results

  18. changes in AHI supine position

    Time frame: 6 months 2 years

    Polysomnographic results

  19. changes in AHI in REM

    Time frame: 6 months and 2 years

    Polysomnographic results

  20. changes in total sleep time

    Time frame: 6 months and 2 years

    Polysomnograåhic results

  21. changes in RDI

    Time frame: 6 months and 2 years

    Polysomnographic results; RDI is the sum of AHI and RERA index

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Acronym: SKUP3

Important dates

Study start
2007
Primary completion
2011
Study completion
2014
First posted
Aug 8, 2012
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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