Status:
COMPLETED
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
Lead Sponsor:
Lacrima Medical LTD
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia
Eligibility Criteria
Inclusion
- Main
- Adult subjects, 18 years of age and older at screening
- Diagnosis of primary insomnia based on International Classification of Sleep Disorders, revision no 2
- Total score of Pittsburgh Sleep Quality questionnaire is \> 5
- Latency to persistent sleep is \> 30 minutes based on Pittsburgh questionnaire
- Able to understand and provide written informed consent
- Main
Exclusion
- Patients using any pharmacological treatments for insomnia for 14 days
- Patients currently using stimulants drugs 7 days
- Patients currently using antidepressants causing sleepiness
- Patients who are unable to commit to avoid consumption alcohol during the study
- Patients who are unable to commit to avoid consumption caffeine after 12 pm
- Patients who have a clinical significant or unstable medical or surgical condition
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02236845
Start Date
October 1 2014
End Date
August 1 2016
Last Update
August 16 2016
Active Locations (1)
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1
Rambam Health Care Campus
Haifa, Israel