Nasal Obstruction in Sleep Apnea Patients Compared to the General Population

This study is currently recruiting participants.
Verified October 2013 by Norwegian University of Science and Technology
Sponsor:
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: October 8, 2013
Last verified: October 2013

January 18, 2011
October 8, 2013
December 2010
December 2014   (final data collection date for primary outcome measure)
  • patient reported nasal obstruction [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    assessed by a 10-point visual analogue scale (VAS) and Sino Nasal Outcome Score(SNOT-20) questionnaire.
  • objective nasal obstruction [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Not Provided
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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
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Non-Probability Sample

Patients: St Olavs Hospital, Trondheim, Norway Controls: Community sample, residents of Trøndelag, Norway

  • Obstructive Sleep Apnoea Syndrome
  • Nasal Obstruction
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  • sleep apnea
    100 patients suffering from obstructive sleep apnea syndrome
  • controls
    100 subjects matching cases to age, sex, and body weight
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ???

Exclusion Criteria:

  • ???
Both
18 Years to 70 Years
Yes
Contact: Mads Henrik S. Moxness, MD 004799035515 madsmox@gmail.com
Contact: Ståle Nordgård, MD, Phd stale.nordgard@ntnu.no
Norway
 
NCT01282125
OSAS og nasalstenose
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Sorlandet Hospital HF
Principal Investigator: Mads Henrik S. Moxness, MD Aleris/NTNU
Norwegian University of Science and Technology
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP