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Nasal Obstruction in Sleep Apnea Patients Compared to the General Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282125
First Posted: January 24, 2011
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sorlandet Hospital HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
January 18, 2011
January 24, 2011
March 13, 2017
December 2010
November 2016   (Final data collection date for primary outcome measure)
  • 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).
Peak Nasal Inspiratory Flow measured in litres per minute [ Time Frame: 3 months after surgery ]
Complete list of historical versions of study NCT01282125 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Nasal Obstruction in Sleep Apnea Patients Compared to the General Population
A Comparative Study of Nasal Obstruction in a Sleep Apnea Population Compared to the General Population

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
Patients: St Olavs Hospital, Trondheim, Norway Controls: Community sample, residents of Trøndelag, Norway
  • Obstructive Sleep Apnoea Syndrome
  • Nasal Obstruction
Not Provided
  • sleep apnea
    100 patients suffering from obstructive sleep apnea syndrome
  • controls
    100 subjects matching cases to age, sex, and body weight
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.
 
Completed
217
November 2016
November 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ???

Exclusion Criteria:

  • ???
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01282125
OSAS og nasalstenose
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Sorlandet Hospital HF
Principal Investigator: Ståle S. Nordgård, MD PhD Aleris/NTNU
Norwegian University of Science and Technology
March 2017