Nasal Obstruction in Sleep Apnea Patients Compared to the General Population
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2015 by Norwegian University of Science and Technology
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: January 16, 2015
Last verified: January 2015
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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 ] [ 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: | October 2015 (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
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: | January 16, 2015 |
| 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:
|
Nasal Obstruction Sleep Apnea Syndromes Sleep Apnea, Obstructive Airway Obstruction Apnea Dyssomnias Nervous System Diseases |
Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Disorders Sleep Disorders, Intrinsic |
ClinicalTrials.gov processed this record on February 27, 2015