Nasal Obstruction in Sleep Apnea Patients Compared to the General Population
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2016 by Norwegian University of Science and Technology
Sponsor:
Norwegian University of Science and Technology
Collaborator:
Sorlandet Hospital HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01282125
First received: January 18, 2011
Last updated: August 16, 2016
Last verified: August 2016
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 18, 2011 | ||||||||
| Last Updated Date | August 16, 2016 | ||||||||
| Start Date ICMJE | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Peak Nasal Inspiratory Flow measured in litres per minute [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01282125 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE |
VAS scale, the subjects will put a mark at a 10 cm line, where 0 defines no subjective discomfort and 10 defines the maximum subjective discomfort [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Nasal Obstruction in Sleep Apnea Patients Compared to the General Population | ||||||||
| Official Title ICMJE | A Comparative Study of Nasal Obstruction in a Sleep Apnea Population Compared to the General Population | ||||||||
| Brief Summary | Recent clinical findings of research at Trondheim University Hospital suggest that surgical correction of the nose septum in addition to volume reduction of the nose cavity may be beneficial in patients who suffer from both nose obstruction and obstructive sleep apnea syndrome(data not yet published). This study aims to compare nose obstruction prevalence in sleep apnea patients and the general population |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients: St Olavs Hospital, Trondheim, Norway Controls: Community sample, residents of Trøndelag, Norway | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2016 | ||||||||
| Estimated Primary Completion Date | December 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years (Adult, Senior) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Norway | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01282125 | ||||||||
| Other Study ID Numbers ICMJE | OSAS og nasalstenose | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Plan to Share Data | Not Provided | ||||||||
| IPD Description | Not Provided | ||||||||
| Responsible Party | Norwegian University of Science and Technology | ||||||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||||||
| Collaborators ICMJE | Sorlandet Hospital HF | ||||||||
| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||||||
| Verification Date | August 2016 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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