RCT Between UPP and Controls in Adult OSA

March 9, 2023 updated by: Danielle Friberg, Karolinska University Hospital

Randomized Control Trial Between Uvulopalatoplasty and Delayed Surgery (Controls)

To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Two arms: the intervention group undergo uvulopalatoplasty one month after baseline polysomnography (PSG1) and a PSG2 6 months after surgery .

The control group perform PSG 1 and are then waiting 6 months, thereafter undergo PSG2, then surgery and PSG3 6 months after surgery. All patients are followed for four years with PSG. Patients fill in questionnaires at PSG sessions, and blood pressure control the morning after.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 141 86
        • Orl dep, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AHI of 15 or more
  • Friedmans stage I+II
  • Tonsil size 0-1
  • BMI<34
  • ESS värde >7
  • Failed treatment with CPAP and mandibular device

Exclusion Criteria:

  • Severe cardiovascular or neurological disease
  • ASA IV
  • Not interested in surgical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Uvulopalatoplasty
Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle
Procedure: UPP
surgery with cold steel in general anesthesia
Other Names:
  • Uvulopalatoplasty
No Intervention: Controls
Only waiting 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography: group differences in changes of apnea-hypopnea index (AHI)
Time Frame: 6 months
compare the two groups of changes in number of apneas and hypopneas per sleep hour measured with inlab polysomnography, between baseline and follow-up
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire: group differences in changes of daytime sleepiness
Time Frame: 6 months
using validated questionnaire Epworth sleepiness scale measure changes between baseline and follow-up and compare the differences between groups
6 months
Questionnaire: group differences in changes of general health
Time Frame: 6 months
using validated question
6 months
Blood pressure: group differences in changes of blood pressure
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography: changes of AHI between baseline and 4 years postoperatively
Time Frame: 4 years
The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.
4 years
Questionnaire: changes of daytime sleepiness between baseline and 4 years postoperatively
Time Frame: 4 years
The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.
4 years
Questionnaire: changes of general health between baseline and after 4 years postoperatively
Time Frame: 4 years
The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.
4 years
Postoperative bleeding complications
Time Frame: 6 months
postop bleeding in milliliter
6 months
Postoperative days at hospital
Time Frame: 6 months
report number of days at hospital postop
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Study Director: Bo Tideholm, Md, PhD, ORL-dep, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

December 10, 2015

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/755-31/2B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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