Chronic Insomnia
Conditions
Keywords
Insomnia, medical device, sleep latency
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
Interventions
DEVICELacrima Medical Device and sham comparator
Sponsors
Lacrima Medical LTD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse events | Up to 37 days |
Secondary
| Measure | Time frame |
|---|---|
| Change in sleep latency time based on sleep actigraph | 28 days |
Other
| Measure | Time frame |
|---|---|
| Change in sleep latency time based on sleep diaries | 28 days |
Countries
Israel
Outcome results
None listed