Nasal Obstruction in Sleep Apnea Patients Compared to the General Population
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ClinicalTrials.gov Identifier: NCT01282125 |
Recruitment Status
:
Completed
First Posted
: January 24, 2011
Last Update Posted
: March 13, 2017
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Sponsor:
Norwegian University of Science and Technology
Collaborator:
Sorlandet Hospital HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
Tracking Information | |||||
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First Submitted Date | January 18, 2011 | ||||
First Posted Date | January 24, 2011 | ||||
Last Update Posted Date | March 13, 2017 | ||||
Actual Study Start Date | December 2010 | ||||
Actual Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
Peak Nasal Inspiratory Flow measured in litres per minute [ Time Frame: 3 months after surgery ] | ||||
Change History | Complete list of historical versions of study NCT01282125 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures |
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 ] | ||||
Current Other Outcome Measures | Not Provided | ||||
Original Other Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Nasal Obstruction in Sleep Apnea Patients Compared to the General Population | ||||
Official Title | 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 | Observational | ||||
Study Design | 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 |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Moxness MH, Bugten V, Thorstensen WM, Nordgård S, Bruskeland G. A comparison of minimal cross sectional areas, nasal volumes and peak nasal inspiratory flow between patients with obstructive sleep apnea and healthy controls. Rhinology. 2016 Dec 1;54(4):342-347. doi: 10.4193/Rhin16.085. | ||||
* 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 | Completed | ||||
Actual Enrollment |
217 | ||||
Original Estimated Enrollment |
200 | ||||
Actual Study Completion Date | November 2016 | ||||
Actual Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Norway | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01282125 | ||||
Other Study ID Numbers | OSAS og nasalstenose | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Norwegian University of Science and Technology | ||||
Study Sponsor | Norwegian University of Science and Technology | ||||
Collaborators | Sorlandet Hospital HF | ||||
Investigators |
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PRS Account | Norwegian University of Science and Technology | ||||
Verification Date | March 2017 |