In Vivo Measurements of Nasal Ciliary Beat Frequency by Using Interferometry

Primary Ciliary Dyskinesia Clinical Trial

Official title:

In Vivo Measurements of Nasal Ciliary Beat Frequency by Using Interferometry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02699177
• Other study ID #: 0366-15-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 29, 2015
• Last updated: February 29, 2016
• Start date: April 2016
• Est. completion date: July 2019

Study information

• Verified date: February 2016
• Source: Hadassah Medical Organization
• Contact: David Shoseyov, MD
• Phone: 972-507874091
• Email: shoseyov[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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

Description:

Background Mucociliary clearance of the airways depends on ciliary movement by ciliated cells that cover the entire airway and the sinuses. In many airway diseases the mucociliary clearance is affected by injury caused by smoke, viruses, other infectious organisms or genetic diseases that are called Primary Ciliary Dyskinesia (PCD).

The diagnosis of PCD is based on a combination of clinical findings such as bronchiectasis, chronic sinusitis, chronic otitis media and immotile sperms.

In addition, in tests performed in the pulmonary laboratory nasal nitric oxide levels may be low.

Samples obtained by nasal brush biopsy can be analyzed and the ciliary movement recorded by video microscopy. Ciliary beat frequency (CBF) can be calculated in freshly isolated samples but also after growing the tissue in cell culture.

Furthermore, ciliated cells can be analyzed by electron microscopy to detect defects in the microscopic structure of the cilia.

The major problem encountered by all these assays is that they are performed under in vitro conditions and not in the natural environment of the cells where the acidity (pH), temperature, electrolytes etc. may be very different.

Moreover, genetic testing is limited to mutations known to cause PCD, ruling out mutations not yet discovered.

Therefore a method is needed to unequivocally measure ciliary movement in the natural environment.

Goal

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.

Methods The protocol has been approved by the local Institutional Review Board (IRB) of the Hadassah Medical Center, Jerusalem, Israel

Equipment:

1. High Speed High Video Microscope built to specifications needed for this study based on a commercially available high speed video system.

2. The green light source (LED) used consists of a spot of 3mm diameter and has an energy of 10 milli Watt ( equal to 1Kilowatt/square meter)

3. Video camera (manufactured by SONY Inc, Japan)

Patients:

Patients referred for ciliary brush biopsy will be asked to sign the informed consent and to be enrolled into the study.

Patients will be examined by having a high speed digital video camera placed close to the nasal cavity in order to photograph the area of interest. The camera lens will be off focus and the reflected light from the nasal mucosa will be recorded. This reflected light recording will be analyzed to obtain the CBF, heart rate and respiratory rate.

After the recording the patient will proceed to the nasal brush ciliary biopsy. The cells will be analyzed by a CBF will be calculated from several areas of the smear.

Safety measures:

All participating patients will wear a protective cover over their eyes during photography.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients referred for Ciliary Brush Biopsy

Exclusion Criteria:

• Active nasal bleeding

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Dyskinesias
• Kartagener Syndrome
• Primary Ciliary Dyskinesia

Intervention

Device:
• CBF measurements
CBF measurements

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Ciliary beat frequency (CBF) measured by interferometry	In vivo measurements of CBF analysing the reflected light from the nasal cavity	5 minutes	No