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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 March 2023 |
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Main ID: |
NCT02522247 |
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Date of registration:
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10/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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RCT Between UPP and Controls in Adult OSA
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Scientific title:
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Randomized Control Trial Between Uvulopalatoplasty and Delayed Surgery (Controls) |
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Date of first enrolment:
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November 23, 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02522247 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Bo Tideholm, Md, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ORL-dep, Karolinska University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obstructive Sleep Apnea
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Intervention(s)
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Procedure: UPP
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Primary Outcome(s)
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Polysomnography: group differences in changes of apnea-hypopnea index (AHI)
[Time Frame: 6 months]
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Secondary Outcome(s)
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Questionnaire: group differences in changes of daytime sleepiness
[Time Frame: 6 months]
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Blood pressure: group differences in changes of blood pressure
[Time Frame: 6 months]
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Questionnaire: group differences in changes of general health
[Time Frame: 6 months]
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Secondary ID(s)
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2015/755-31/2B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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