Correlation of Nasal Volume, Cross-Sectional Area With Nasalance Scores Measured by Acoustic Rhinometry and Nasometry

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00147940
First received: September 2, 2005
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

The purpose of our study is to correlate nasal volume and cross-sectional area with nasalance scores. We will measure nasal volume and cross-sectional area with acoustic rhinometry. Nasalance scores will be determined by Nasometry.

Acoustic rhinometry is a means to study the volume and cross-sectional areas of the nasal cavity in a non-invasive, rapid, convenient and reliable manner. Acoustic rhinometry has the unique advantage of being completely non-invasive, and thus is able to measure nasal patency without the confounding effects of probes or invasive monitoring.

Nasometry is a technique to measure the oral and nasal components of nasalance. Nasalance is the objective measure of the nasal component of speech that is determined by the ratio of sound pressure emitted from the nasal and oral cavities during speech. Nasality is the term used to characterize the nasal component of speech, and is a subjective measure.

Eleven healthy subjects underwent acoustic rhinometry pre and post decongestion using oxymetazoline 0.05% nasal spray. Nasalance scores were based on the readings of three passages: rainbow, zoo, and nasal.


Condition Intervention Phase
Allergy
Procedure: Acoustic rhinometry (procedure)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Correlation of Nasal Volume and Cross-Sectional Area With Nasalance Scores as Measured by Acoustic Rhinometry and Nasometry

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Nasal volume

Secondary Outcome Measures:
  • Nasalance scores

Estimated Enrollment: 20
Study Start Date: April 2004
Estimated Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Acoustic rhinometry is a technique that utilizes sound waves to measure nasal patency. The reflections of the waves off of the nasal structures allow one to assess the volume and cross sectional area of the nasal cavity. It is a non-invasive procedure that can be performed in a rapid, convenient, and reliable manner. There is minimal discomfort for the patient and it can be performed easily in the office. There is no distortion of nasal anatomy or functioning as a result of the procedure.

Nasometry is a technique to measure the oral and nasal components of nasalance. Nasalance is an objective measure of the nasal component of speech that is determined by the ratio of acoustic pressures emitted from the nasal and oral cavities. 'Nasality' is the term used to characterize the nasal component of speech, and is a subjective measure.

The Nasometer (Kay Elemetrics Corp Lincoln Park, NJ) is a computer-based device that analyzes acoustic energy that is emitted from the oral and the nasal cavity during speech. It consists of two microphones that are separated by a plate. The upper microphone measures nasally emitted acoustic energy, and the lower microphone measure the acoustic energy emitted from the oral cavity.

Nasalance is an important measure in speech pathology. In situations where velopharyngeal competence is in question, nasometry objectively documents the nasal component of speech as normal, hypemasal or hyponasal. It has been found to be of tremendous benefit in the management of patients with cleft palate and velopharyngeal incompetence. The subject is relaxed, and is fitted with a headgear apparatus. This apparatus is placed such that a plate lies in a horizontal plane that rests midway between the nose and the mouth. There are microphones on the upper and lower surfaces of the plate that capture sound energy produced from the nasal and oral cavities respectively. The subject is then asked to read standard passages. The three most commonly used passages are described here, and will be used in our study. The 'Rainbow' passage is most representative of standard English speech. The 'Zoo' passage has no nasal consonants, and the 'Nasal' passage has the highest number of nasal consonants.

While the subject is reading, the microphone captures sound pressure levels which are emitted from the nasal and the oral cavities. This data is analyzed by the attached computer and presented graphically. The computer also provides a nasalance score for each of three above- mentioned passages. Normative data is available for each of these passages for adults and children. By comparing the data obtained from the subject with the normative means and standard deviations, the investigator can categorize the subject's voice as normal, hyponasal or hypernasal. The nasalance score that is generated can also be used to monitor the efficacy of speech therapy and surgical interventions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults over the age of 18 years who no gross nasal deformity

Exclusion Criteria:

  • Pregnant or nursing females
  • Subjects younger than 18 years
  • Allergy to the drug oxymetazoline
  • Inability to read a simple standard English passage
  • History of heart disease, hypertension, renal, liver or lung disease
  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: NCT00147940

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Daniel Martin, M.D. University of Chicago
  More Information

Publications:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00147940     History of Changes
Other Study ID Numbers: 13093A
Study First Received: September 2, 2005
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Allergy

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014