NCT01282125

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

5.9 years

First QC Date

January 18, 2011

Last Update Submit

March 10, 2017

Conditions

Obstructive Sleep Apnoea SyndromeNasal Obstruction

Keywords

general populationprevalenceNorway

Outcome Measures

Primary Outcomes (2)

  • patient reported nasal obstruction

    assessed by a 10-point visual analogue scale (VAS) and Sino Nasal Outcome Score(SNOT-20) questionnaire.

    1 week

  • objective nasal obstruction

    measured by acoustical rhinometry and Peak Nasal Inspiratory Flow (PNIF).

    1 week

Study Arms (2)

sleep apnea

100 patients suffering from obstructive sleep apnea syndrome

controls

100 subjects matching cases to age, sex, and body weight

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ???

You may not qualify if:

  • ???

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital Trondheim University Hospital

Trondheim, 7020, Norway

Location

Related Publications (1)

  • Moxness MH, Bugten V, Thorstensen WM, Nordgard S, Bruskeland G. A comparison of minimal cross sectional areas, nasal volumes and peak nasal inspiratory flow between patients with obstructive sleep apnea and healthy controls. Rhinology. 2016 Dec 1;54(4):342-347. doi: 10.4193/Rhino16.085.

    PMID: 27591949RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveNasal Obstruction

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesNose DiseasesAirway ObstructionRespiratory InsufficiencyOtorhinolaryngologic Diseases

Study Officials

  • Ståle S. Nordgård, MD PhD

    Aleris/NTNU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 24, 2011

Study Start

December 1, 2010

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations

NO(1)