Eyelid Movement DisordersNCT02309814
Eyelid Movement Sensor Device- Blinking Characterizing
A study testing eyelid motion sensor device (Hall-probe) in people with Eyelid Movement Disorders, run by HaEmek Medical Center, Israel.
Trial summary
The investigators have developed a simple to use device that facilitates the monitoring of the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and graphic presentation of the results. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Eyelid Movement Disorders
- What is being tested?
- eyelid motion sensor device (Hall-probe)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy 18-67 year olds with no eye medical history
Who cannot join
- pregnancy
- head trauma history
- using contact lens
About this study
The investigators have developed a simple to use device that facilitates the monitoring of the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and graphic presentation of the results. the device system consists 3 components : glasses for the patient including magneto sensitive probes, hardware and dedicated software.
Our purpose is to characterize eyelid motion in normal population. The methods include measuring each patient 10 minutes during watching a short movie.
Read the detailed description
Essentially, for Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid.
- Conditions
- Eyelid Movement Disorders
- Being tested
- eyelid motion sensor device (Hall-probe)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eyelid motion sensor device (Hall-probe)Device
all volunteers will wear the eyelid motion sensor device (Hall-probe) (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance
| Study group | Role | What they receive |
|---|---|---|
| eyelid motion sensor device | Experimental | all volunteers will wear the monitor eyelid sensor device (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance. Receives: Device: eyelid motion sensor device (Hall-probe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate and describe measurable blinking character in normal population.(Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, daniel briscoe, HaEmek Medical Center, Israel
- Investigators
- daniel briscoe, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309814
- Sponsor's protocol ID
- 0133-13-EMC
- Status last verified
- Sep 2016
- First submitted
- 1 Dec 2014
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eyelid Movement Sensor Device- Blinking Characterizing
- ClinicalTrials.gov ID
- NCT02309814
- Acronym / sponsor ID
- 0133-13-EMC
- Conditions
- Eyelid Movement Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have developed a simple to use device that facilitates the monitoring of the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and graphic presentation of the results. the device system consists 3 components : glasses for the patient including magneto sensitive probes, hardware and dedicated software.
Our purpose is to characterize eyelid motion in normal population. The methods include measuring each patient 10 minutes during watching a short movie.
Detailed description
Essentially, for Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eyelid motion sensor device | Experimental | Device: eyelid motion sensor device (Hall-probe)all volunteers will wear the monitor eyelid sensor device (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy 18-67 year olds with no eye medical history
Key exclusion criteria (3 listed)
- pregnancy
- head trauma history
- using contact lens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eyelid motion sensor device (Hall-probe)all volunteers will wear the eyelid motion sensor device (Hall-probe) (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance | Device | eyelid motion sensor device |
Primary outcome
Demonstrate and describe measurable blinking character in normal population.(Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid)
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
daniel briscoe principal investigator
haemek medical center
Questions about this trial
What is this clinical trial studying?
A study testing eyelid motion sensor device (Hall-probe) in people with Eyelid Movement Disorders, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate and describe measurable blinking character in normal population.(Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.