Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

Lacrima Medical

Status: Completed

Conditions: Chronic Insomnia

Treatments: Device: Lacrima Medical Device and sham comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02236845

LM002

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups

Lacrima medical active device

Experimental group

Treatment:

Device: Lacrima Medical Device and sham comparator

Lacrima medical sham device

Sham Comparator group

Treatment:

Device: Lacrima Medical Device and sham comparator