Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

Pilot, Randomized, Cross-over Study to Evaluate Safety and Clinical Effect of Lacrima Medical Device in Patients With Chronic Insomnia

The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia

Main Inclusion Criteria:

1. Adult subjects, 18 years of age and older at screening
2. Diagnosis of primary insomnia based on International Classification of Sleep Disorders, revision no 2
3. Total score of Pittsburgh Sleep Quality questionnaire is > 5
4. Latency to persistent sleep is > 30 minutes based on Pittsburgh questionnaire
5. Able to understand and provide written informed consent

Main Exclusion Criteria:

1. Patients using any pharmacological treatments for insomnia for 14 days
2. Patients currently using stimulants drugs 7 days
3. Patients currently using antidepressants causing sleepiness
4. Patients who are unable to commit to avoid consumption alcohol during the study
5. Patients who are unable to commit to avoid consumption caffeine after 12 pm
6. Patients who have a clinical significant or unstable medical or surgical condition