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Nasal Obstruction in Sleep Apnea Patients Compared to the General Population

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 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 27, 2014
Last verified: October 2014
  Purpose

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


Condition
Obstructive Sleep Apnoea Syndrome
Nasal Obstruction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Comparative Study of Nasal Obstruction in a Sleep Apnea Population Compared to the General Population

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
sleep apnea
100 patients suffering from obstructive sleep apnea syndrome
controls
100 subjects matching cases to age, sex, and body weight

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • ???

Exclusion Criteria:

  • ???
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282125

Contacts
Contact: Mads Henrik S. Moxness, MD 004799035515 madsmox@gmail.com
Contact: Ståle Nordgård, MD, Phd stale.nordgard@ntnu.no

Locations
Norway
St Olavs Hospital Trondheim University Hospital Recruiting
Trondheim, Norway, 7020
Contact: Ståle Nordgård, MD, Phd       stale.nordgard@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
Sorlandet Hospital HF
Investigators
Principal Investigator: Mads Henrik S. Moxness, MD Aleris/NTNU
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01282125     History of Changes
Other Study ID Numbers: OSAS og nasalstenose
Study First Received: January 18, 2011
Last Updated: October 27, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
general population
prevalence
Norway

Additional relevant MeSH terms:
Apnea
Nasal Obstruction
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Airway Obstruction
Dyssomnias
Nervous System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiration Disorders
Respiratory Insufficiency
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 24, 2014