Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

Chronic Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236845
• Other study ID #: LM002
• Status: Completed
• Phase: N/A
• First received: September 6, 2014
• Last updated: August 14, 2016
• Start date: October 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Lacrima Medical LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Lacrima Medical Device and sham comparator

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Lacrima Medical LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in sleep latency time based on sleep diaries		28 days	No
Primary	Rate of adverse events		Up to 37 days	No
Secondary	Change in sleep latency time based on sleep actigraph		28 days	No