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Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

Primary Purpose

Chronic Insomnia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Lacrima Medical Device and sham comparator
Sponsored by
Lacrima Medical LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, medical device, sleep latency

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rambam Health Care Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Lacrima medical active device

Lacrima medical sham device

Arm Description

Outcomes

Primary Outcome Measures

Rate of adverse events

Secondary Outcome Measures

Change in sleep latency time based on sleep actigraph

Full Information

First Posted
September 6, 2014
Last Updated
August 14, 2016
Sponsor
Lacrima Medical LTD
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1. Study Identification

Unique Protocol Identification Number
NCT02236845
Brief Title
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
Official Title
Pilot, Randomized, Cross-over Study to Evaluate Safety and Clinical Effect of Lacrima Medical Device in Patients With Chronic Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lacrima Medical LTD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
Insomnia, medical device, sleep latency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacrima medical active device
Arm Type
Experimental
Arm Title
Lacrima medical sham device
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Lacrima Medical Device and sham comparator
Primary Outcome Measure Information:
Title
Rate of adverse events
Time Frame
Up to 37 days
Secondary Outcome Measure Information:
Title
Change in sleep latency time based on sleep actigraph
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Change in sleep latency time based on sleep diaries
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Adult subjects, 18 years of age and older at screening Diagnosis of primary insomnia based on International Classification of Sleep Disorders, revision no 2 Total score of Pittsburgh Sleep Quality questionnaire is > 5 Latency to persistent sleep is > 30 minutes based on Pittsburgh questionnaire Able to understand and provide written informed consent Main Exclusion Criteria: Patients using any pharmacological treatments for insomnia for 14 days Patients currently using stimulants drugs 7 days Patients currently using antidepressants causing sleepiness Patients who are unable to commit to avoid consumption alcohol during the study Patients who are unable to commit to avoid consumption caffeine after 12 pm Patients who have a clinical significant or unstable medical or surgical condition
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel

12. IPD Sharing Statement

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Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

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