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In Vivo Measurements of Nasal Ciliary Beat Frequency by Using Interferometry

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ClinicalTrials.gov Identifier: NCT02699177
Recruitment Status : Not yet recruiting
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
SHOSEYOV DAVID, Hadassah Medical Organization

Brief Summary:
  1. Assessment of a high speed video camera with a green light source for the measurement of ciliary beat frequency (CBF) in the nasal airways of patients.
  2. Assessments of the effect of drugs and other therapies on CBF using the study system.
  3. Comparison of results with standard methods such as ciliary brush biopsies

Condition or disease Intervention/treatment
Primary Ciliary Dyskinesia Device: CBF measurements

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: In Vivo Measurements of Nasal Ciliary Beat Frequency by Using Interferometry
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019


Group/Cohort Intervention/treatment
Suspected PCD but negative

CBF measurements:

  1. Patients with suspected PCD will have their nasal cavity photographed using a Sony-video camera that will record the reflected light of a green LED bulb.Ciliary beat frequency (CBF) will be calculated by interferometry using a program developed by the PI.
  2. Patients will undergo a nasal brush biopsies. The fresh biopsies will be analyzed by high-speed video microscopy to calculate CBF.
  3. The two methods will be compared.
Device: CBF measurements
CBF measurements
Other Name: Ciliary brush biopsy

Suspected PCD but positive

CBF measurements:

  1. Patients with suspected PCD will have their nasal cavity photographed using a Sony-video camera that will record the reflected light of a green LED bulb.Ciliary beat frequency (CBF) will be calculated by interferometry using a program developed by the PI.
  2. Patients will undergo a nasal brush biopsies. The fresh biopsies will be analyzed by high-speed video microscopy to calculate CBF.
  3. The two methods will be compared.
Device: CBF measurements
CBF measurements
Other Name: Ciliary brush biopsy




Primary Outcome Measures :
  1. Ciliary beat frequency (CBF) measured by high speed video microscopy [ Time Frame: 5 minutes ]
    Ex vivo measurements of CBF analysing high speed video records of nasal brush biopsies

  2. Ciliary beat frequency (CBF) measured by interferometry [ Time Frame: 5 minutes ]
    In vivo measurements of CBF analysing the reflected light from the nasal cavity


Biospecimen Retention:   Samples Without DNA
nasal brush biopsies, EM samples


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected PCD
Criteria

Inclusion Criteria:

  • Patients referred for Ciliary Brush Biopsy

Exclusion Criteria:

  • Active nasal bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699177


Contacts
Contact: David Shoseyov, MD 972-507874091 shoseyov@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91240
Contact: David Shoseyov, MD    972-2-5844430/1    shoseyov@hadassah.org.il   
Sub-Investigator: Reuven Tzabari, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: David Shoseyov, MD Hadassah Medical Organization

Responsible Party: SHOSEYOV DAVID, Dr., Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02699177     History of Changes
Other Study ID Numbers: 0366-15-HMO-CTIL
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by SHOSEYOV DAVID, Hadassah Medical Organization:
ciliary beat frequency,

Additional relevant MeSH terms:
Dyskinesias
Ciliary Motility Disorders
Kartagener Syndrome
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Bronchiectasis
Bronchial Diseases
Respiratory System Abnormalities
Dextrocardia
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Situs Inversus