RCT of the Effect of Uvulopalatopharyngoplasty Compared to Expectancy in Patients With Obstructive Sleep Apnea (SKUP3)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Karolinska University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Danielle Friberg, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01659671
First received: August 6, 2012
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea Syndrome
Procedure: Uvulopalatopharyngoplasty

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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Changes in apnea-hypopnea index [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Changes in Epworth sleepiness scale [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Changes in Oxygen desaturation index [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    Oxygen desaturation index (ODI) is the number of oxygen desaturations of 3 % or more per sleep hour.

  • changes in blood samples [ Time Frame: 6 months 2 years ] [ Designated as safety issue: No ]
    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

  • changes in score of SF 36 quality of life questionnaire [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    QoL SF 36 validated questionnaire

  • changes in blood pressure [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    systolic and diastolic morning pressure from arm

  • changes in vigilance [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    modified Osler test

  • number of patients with serious complications from surgery [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • number of patients with side-effects from surgery [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    answers from a local questionnaire regaring pharyngeal side-effects

  • Changes in score of FOSQ questionnaire [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    Validated questionnaire designed for patients with obstructive sleep apnea syndrome

  • identifying success factors for outcome of surgical intervention [ Time Frame: 6 months 2 years ] [ Designated as safety issue: No ]
    Correlate for example tonsil size and tongue position (stageing system) with changes in AHI

  • changes in arousal index [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results

  • changes in lowest oxygen saturation during sleep [ Time Frame: 6 months 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results

  • changes in ODI during REM sleep [ Time Frame: 6 months 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results

  • changes in ODI in supine position [ Time Frame: 6 months 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results

  • changes in time in supine position [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results

  • changes in Body Mass Index [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
  • changes in RERA index [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results, RERA are the respiratory effort related arousals during sleep

  • changes in mean length apneas and hypopneas [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results

  • changes in AHI supine position [ Time Frame: 6 months 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results

  • changes in AHI in REM [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results

  • changes in total sleep time [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    Polysomnograåhic results

  • changes in RDI [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: No ]
    Polysomnographic results; RDI is the sum of AHI and RERA index


Enrollment: 65
Study Start Date: June 2007
Estimated Study Completion Date: May 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Uvulopalatopharyngoplasty
One arm is Uvulopalatopharyngoplasty(intervention group of 32 patients), one arm is expectancy (control group of 33 patients). After six months the controls have delayed surgery and then both groups are followed for two years
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.
Active Comparator: Control
After six months the controls have delayed surgery then are followed for 2 year
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659671

Locations
Sweden
ORL dep, Karolinska University Hospital
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
Principal Investigator: Danielle K Friberg, MD, PhD, Associate professor Karolinska University Hospital, Karolinska Institutet
  More Information

No publications provided by Karolinska University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Danielle Friberg, Associate Professor, MD, Senior Surgeon, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01659671     History of Changes
Other Study ID Numbers: 2007/449-31/3, Ö 21-2007, 2007/449-31/3, Ö 21-2007
Study First Received: August 6, 2012
Last Updated: August 8, 2012
Health Authority: Sweden: Swedish Research Council

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014