Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
Not Applicable
Completed
- Conditions
- Chronic Insomnia
- Registration Number
- NCT02236845
- Lead Sponsor
- Lacrima Medical LTD
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Rate of adverse events Up to 37 days
- Secondary Outcome Measures
Name Time Method Change in sleep latency time based on sleep actigraph 28 days
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the Lacrima Medical Device's clinical effects on chronic insomnia?
How does the Lacrima Medical Device compare to standard-of-care treatments for chronic insomnia in terms of efficacy and safety?
Are there specific biomarkers that predict response to the Lacrima Medical Device in chronic insomnia patients?
What are the potential adverse events associated with the Lacrima Medical Device and how can they be managed?
What are the current trends in medical device development for chronic insomnia, and how does the Lacrima Medical Device fit into this landscape?
Trial Locations
- Locations (1)
Rambam Health Care Campus
🇮🇱Haifa, Israel
Rambam Health Care Campus🇮🇱Haifa, Israel