NCT02522247

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2015

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

First QC Date

August 10, 2015

Last Update Submit

March 9, 2023

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (3)

  • Questionnaire: group differences in changes of daytime sleepiness

    6 months

  • Questionnaire: group differences in changes of general health

    6 months

  • Blood pressure: group differences in changes of blood pressure

    6 months

Other Outcomes (5)

  • Polysomnography: changes of AHI between baseline and 4 years postoperatively

    4 years

  • Questionnaire: changes of daytime sleepiness between baseline and 4 years postoperatively

    4 years

  • Questionnaire: changes of general health between baseline and after 4 years postoperatively

    4 years

  • +2 more other outcomes

Study Arms (2)

Uvulopalatoplasty

ACTIVE COMPARATOR

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

Procedure: UPP

Controls

NO INTERVENTION

Only waiting 6 months

Interventions

UPPPROCEDURE

surgery with cold steel in general anesthesia

Also known as: Uvulopalatoplasty
Uvulopalatoplasty

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orl dep, Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Bo Tideholm, Md, PhD

    ORL-dep, Karolinska University Hospital

    STUDY DIRECTOR
0

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

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 13, 2015

Primary Completion

December 10, 2015

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

SE(1)