NCT02236845

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

September 6, 2014

Last Update Submit

August 14, 2016

Conditions

Chronic Insomnia

Keywords

Insomnia, medical device, sleep latency

Outcome Measures

Primary Outcomes (1)

  • Rate of adverse events

    Up to 37 days

Secondary Outcomes (1)

  • Change in sleep latency time based on sleep actigraph

    28 days

Other Outcomes (1)

  • Change in sleep latency time based on sleep diaries

    28 days

Study Arms (2)

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

Lacrima Medical Device and sham comparatorDEVICE
Lacrima medical active deviceLacrima medical sham device

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2014

First Posted

September 11, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

IL(1)