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RCT Between UPP and Controls in Adult OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
UPP
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orl dep, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Uvulopalatoplasty

Controls

Arm Description

Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle

Only waiting 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2015
Last Updated
March 9, 2023
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02522247
Brief Title
RCT Between UPP and Controls in Adult OSA
Official Title
Randomized Control Trial Between Uvulopalatoplasty and Delayed Surgery (Controls)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No patients have been enrolled, and will not. The study was never started
Study Start Date
undefined (undefined)
Primary Completion Date
December 10, 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Uvulopalatoplasty
Arm Type
Active Comparator
Arm Description
Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Only waiting 6 months
Intervention Type
Procedure
Intervention Name(s)
UPP
Other Intervention Name(s)
Uvulopalatoplasty
Intervention Description
surgery with cold steel in general anesthesia
Primary Outcome Measure Information:
Title
Polysomnography: group differences in changes of apnea-hypopnea index (AHI)
Description
compare the two groups of changes in number of apneas and hypopneas per sleep hour measured with inlab polysomnography, between baseline and follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Questionnaire: group differences in changes of daytime sleepiness
Description
using validated questionnaire Epworth sleepiness scale measure changes between baseline and follow-up and compare the differences between groups
Time Frame
6 months
Title
Questionnaire: group differences in changes of general health
Description
using validated question
Time Frame
6 months
Title
Blood pressure: group differences in changes of blood pressure
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Polysomnography: changes of AHI between baseline and 4 years postoperatively
Description
The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.
Time Frame
4 years
Title
Questionnaire: changes of daytime sleepiness between baseline and 4 years postoperatively
Description
The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.
Time Frame
4 years
Title
Questionnaire: changes of general health between baseline and after 4 years postoperatively
Description
The control group is operated with uvulopalatoplasty (delayed surgery) after 6 months waiting. This outcome is for all 100 patients.
Time Frame
4 years
Title
Postoperative bleeding complications
Description
postop bleeding in milliliter
Time Frame
6 months
Title
Postoperative days at hospital
Description
report number of days at hospital postop
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Tideholm, Md, PhD
Organizational Affiliation
ORL-dep, Karolinska University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Orl dep, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

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RCT Between UPP and Controls in Adult OSA

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