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

NCT01659671 | Completed DMC

• 1 other identifier: 2007/449-31/3, Ö 21-2007
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Changes in Epworth sleepiness scale

  6 months and 2 years

Other Outcomes (21)

• Changes in Oxygen desaturation index

  6 months and 2 years

• changes in blood samples

  6 months 2 years

• changes in score of SF 36 quality of life questionnaire

  6 months and 2 years

Study Arms (2)

Uvulopalatopharyngoplasty

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

After six months the controls have delayed surgery then are followed for 2 year

Procedure: Uvulopalatopharyngoplasty

Interventions

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.

Control; Uvulopalatopharyngoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

ORL dep, Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Related Publications (4)

• 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.

  PMID: 29099950 DERIVED

• 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.

  PMID: 28522085 DERIVED

• 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.

  PMID: 26404729 DERIVED

• 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.

  PMID: 23644225 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Danielle K Friberg, MD, PhD, Associate professor

  Karolinska University Hospital, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, Senior Surgeon

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: June 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2014
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

SE (1)