In Vivo Measurements of Nasal Ciliary Beat Frequency by Using Interferometry

NCT02699177 | Unknown

• 1 other identifier: 0366-15-HMO-CTIL
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Assessments of the effect of drugs and other therapies on CBF using the study system.
3. 3.Comparison of results with standard methods such as ciliary brush biopsies

Conditions

Primary Ciliary Dyskinesia

Keywords

ciliary beat frequency,

Outcome Measures

Primary Outcomes (2)

• Ciliary beat frequency (CBF) measured by high speed video microscopy

  Ex vivo measurements of CBF analysing high speed video records of nasal brush biopsies

  5 minutes

• Ciliary beat frequency (CBF) measured by interferometry

  In vivo measurements of CBF analysing the reflected light from the nasal cavity

  5 minutes

Study Arms (2)

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

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

Interventions

CBF measurements DEVICE

CBF measurements

Also known as: Ciliary brush biopsy

Suspected PCD but negative; Suspected PCD but positive

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected PCD

You may qualify if:

• Patients referred for Ciliary Brush Biopsy

You may not qualify if:

• Active nasal bleeding

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91240, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

nasal brush biopsies, EM samples

MeSH Terms

Conditions

Ciliary Motility Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• David Shoseyov, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Shoseyov, MD

CONTACT

972-507874091; shoseyov@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: March 4, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: March 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)