Pilot Study to Clinical Evaluate Lacrima Medical Device i... | NCT02236845

Studies
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

NCT02236845

Sponsor

Lacrima Medical LTD

Status

Completed

Last Update Posted

Aug 16, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Chronic Insomnia

Interventions

Lacrima Medical Device and sham comparator

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jul 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Sep 6, 2014

First Submission Date that Met QC Criteria

Sep 9, 2014

First Posted Date

Sep 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2016

Last Update Posted Date

Aug 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lacrima medical active device	Experimental		Device: Lacrima Medical Device and sham comparator
Lacrima medical sham device	Sham Comparator		Device: Lacrima Medical Device and sham comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lacrima Medical Device and sham comparator	Device		Lacrima medical active device Lacrima medical sham device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of adverse events		Up to 37 days

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus		Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided