NCT03522493

Brief Summary

20 healthy young subjects and 20 healthy older subjects will go through a medical examination. Subjects will be asked for their medical history especially on respiratory and cardiac diseases. All subjects will go through a spirometry test to evaluate their respiratory function. After their medical clearance each subjects will be asked to wear a CBRN respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmH2O resistance, and 15 minutes with 1.2 cmH2O resistance. Throughout the test, Pco2 AND PO2 will be measured. The investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on CO2 accumulation in the mask.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

April 7, 2016

Last Update Submit

April 30, 2018

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • Average CO2 (%)

    Average CO2 (%) will be measured continusly during each of the filters for the two groups.

    45 minutes

Secondary Outcomes (2)

  • Respiratory discomfort (borg scale 1-10)

    45 minutes

  • Average O2 (%)

    45 minutes

Study Arms (2)

Young group

ACTIVE COMPARATOR

This arm include 20 young subjects that will perform the same experiment as the old group for a comparison reasons.

Device: "Yaalom Katom"

Old group

EXPERIMENTAL

This group us the group of interest. This group will wear the mask and is expected to show differences from the younger group.

Device: "Yaalom Katom"

Interventions

"Yaalom Katom"DEVICE

Full face Gas mask

Old groupYoung group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy females and males, with no respiratory, cardio vascular diseases, high blood pressure, psychiatric problem, degenerative nervous system problem, and chronic head ache, muscular disease, or severe acute disease within the two weeks before the study. age 18 and 25, and 55 and 70 years old. Who volunteer to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israel Naval Medical Institute

Haifa, 3109601, Israel

RECRUITING

Central Study Contacts

Dror Ofir, PhD

CONTACT

972-4-8693525meri_mehkar@bezeqint.net

YEHUDA ARIELI, PhD

CONTACT

972-4-8693527yarieli@netvision.net.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

May 11, 2018

Study Start

July 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

May 11, 2018

Record last verified: 2018-04

Locations

IL(1)