Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

Not Applicable

Completed

• Conditions: Chronic Insomnia
• Interventions: Device: Lacrima Medical Device and sham comparator

• 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

Study Timeline

• Study First Submitted: 2014-09-06
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-11
• Study Start: 2014-10
• Primary Completion: 2016-07
• Status Verified: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-14
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lacrima medical sham device	Lacrima Medical Device and sham comparator	-
Lacrima medical active device	Lacrima Medical Device and sham comparator	-

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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel