Nasal Obstruction in Sleep Apnea Patients Compared to the General Population

March 10, 2017 updated by: Norwegian University of Science and Technology

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7020
        • St Olavs Hospital Trondheim University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • ???

Exclusion Criteria:

  • ???

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week
objective nasal obstruction
Time Frame: 1 week
measured by acoustical rhinometry and Peak Nasal Inspiratory Flow (PNIF).
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

Sorlandet Hospital HF

Investigators

  • Principal Investigator: Ståle S. Nordgård, MD PhD, Aleris/NTNU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 21, 2011

First Posted (Estimate)

January 24, 2011

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSAS og nasalstenose

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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