Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

August 14, 2016 updated by: Lacrima Medical LTD

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lacrima medical active device
Device: Lacrima Medical Device and sham comparator
SHAM_COMPARATOR: Lacrima medical sham device
Device: Lacrima Medical Device and sham comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of adverse events
Time Frame: Up to 37 days
Up to 37 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in sleep latency time based on sleep actigraph
Time Frame: 28 days
28 days

Other Outcome Measures

Outcome Measure
Time Frame
Change in sleep latency time based on sleep diaries
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lacrima Medical LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

September 6, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (ESTIMATE)

September 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 14, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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