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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
Sponsor:
Collaborator:
Sorlandet Hospital HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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


Condition or disease
Obstructive Sleep Apnoea Syndrome Nasal Obstruction

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 217 participants
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
Actual Study Start Date : December 2010
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
sleep apnea
100 patients suffering from obstructive sleep apnea syndrome
controls
100 subjects matching cases to age, sex, and body weight


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. objective nasal obstruction [ Time Frame: 1 week ]
    measured by acoustical rhinometry and Peak Nasal Inspiratory Flow (PNIF).


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282125


Locations
Norway
St Olavs Hospital Trondheim University Hospital
Trondheim, Norway, 7020
Sponsors and Collaborators
Norwegian University of Science and Technology
Sorlandet Hospital HF
Investigators
Principal Investigator: Ståle S. Nordgård, MD PhD Aleris/NTNU
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01282125     History of Changes
Other Study ID Numbers: OSAS og nasalstenose
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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