Nasal Obstruction in Sleep Apnea Patients Compared to the General Population

Tracking Information
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; (submitted: November 20, 2012)	patient reported nasal obstruction [ Time Frame: 1 week ]assessed by a 10-point visual analogue scale (VAS) and Sino Nasal Outcome Score(SNOT-20) questionnaire.; objective nasal obstruction [ Time Frame: 1 week ]measured by acoustical rhinometry and Peak Nasal Inspiratory Flow (PNIF).
Original Primary Outcome Measures; (submitted: January 21, 2011)	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; (submitted: January 21, 2011)	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
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Cross-Sectional
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	Obstructive Sleep Apnoea Syndrome; Nasal Obstruction
Intervention	Not Provided
Study Groups/Cohorts	sleep apnea 100 patients suffering from obstructive sleep apnea syndrome; controls 100 subjects matching cases to age, sex, and body weight
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.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: March 10, 2017)	217
Original Estimated Enrollment; (submitted: January 21, 2011)	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: ???
Sex/Gender	Sexes Eligible for Study: All
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	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
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	Principal Investigator: Ståle S. Nordgård, MD PhD Aleris/NTNU
PRS Account	Norwegian University of Science and Technology
Verification Date	March 2017