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Nasal Obstruction in Sleep Apnea Patients Compared to the General Population
This study has been completed.
Sponsor:
Norwegian University of Science and Technology
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: March 10, 2017
Last verified: March 2017
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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 ]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).
| Enrollment: | 217 |
| Actual Study Start Date: | December 2010 |
| Study Completion Date: | November 2016 |
| Primary Completion Date: | November 2016 (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 (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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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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Publications:
| 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: | March 10, 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 |
ClinicalTrials.gov processed this record on August 21, 2017