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Completed

NCT Number: NCT02236845

Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients

The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacrima Medical Device and sham comparator

Device

Primary outcomes

  1. Rate of adverse events

    Time frame: Up to 37 days

Secondary outcomes

  1. Change in sleep latency time based on sleep actigraph

    Time frame: 28 days

Other outcomes

  1. Change in sleep latency time based on sleep diaries

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Lacrima Medical LTD

Industry

Registry information

Official study title

Pilot, Randomized, Cross-over Study to Evaluate Safety and Clinical Effect of Lacrima Medical Device in Patients With Chronic Insomnia

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2014
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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