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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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12 December 2020 |
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Main ID: |
NCT02178826 |
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Date of registration:
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24/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Nocturnal Enuresis and Rapid Maxillary Expansion
NERME |
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Scientific title:
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Nocturnal Enuresis and Rapid Maxillary Expansion - Long Term Effect, Prognostic Factors, Quality of Life and Sleep Quality |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02178826 |
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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: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, 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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Tryggve Nevéus, 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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Uppsala University Hospital |
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Name:
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Farhan Bazargani, DDS, 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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Örebro County Council |
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Name:
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Ingrid M Jönson Ring, DDS, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged 7-14 years old
- At least 7 wet nights out of 14
Exclusion Criteria:
- Daytime incontinence
- Constipation
- ADHD
Age minimum:
7 Years
Age maximum:
14 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Nocturnal Enuresis
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Intervention(s)
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Device: Placebo Appliance
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Device: Rapid Maxillary Expansion
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Primary Outcome(s)
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Enuresis frequency
[Time Frame: 6 months]
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Secondary Outcome(s)
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Sleep quality
[Time Frame: Baseline, 1 month, 6 months]
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QoL
[Time Frame: Baseline, 1 month, 6 months]
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QoL
[Time Frame: Baseline, 6 months]
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Secondary ID(s)
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LUL-2012/379
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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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