Chronic InsomniaNCT02236845
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
A study of Chronic Insomnia, run by Lacrima Medical LTD at 1 site in Israel.
Trial summary
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Insomnia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Chronic Insomnia
- Being tested
- Lacrima Medical Device and sham comparator
- Keywords
- Insomnia, medical device, sleep latency
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacrima Medical Device and sham comparatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Lacrima medical active device | Experimental | Not described Receives: Device: Lacrima Medical Device and sham comparator |
| Lacrima medical sham device | Sham comparator | Not described Receives: Device: Lacrima Medical Device and sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events
Measured: Up to 37 days
Secondary outcomes (1)
Change in sleep latency time based on sleep actigraph
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lacrima Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236845
- Sponsor's protocol ID
- LM002
- Status last verified
- Aug 2016
- First submitted
- 6 Sep 2014
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Randomized, Cross-over Study to Evaluate Safety and Clinical Effect of Lacrima Medical Device in Patients With Chronic Insomnia
- ClinicalTrials.gov ID
- NCT02236845
- Acronym / sponsor ID
- LM002
- Conditions
- Chronic Insomnia
- Keywords
- Insomnia, medical device, sleep latency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lacrima Medical LTDIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacrima Medical Device and sham comparator | Device | Lacrima medical active device, Lacrima medical sham device |
Primary outcome
Rate of adverse events
Time frame: Up to 37 days
1 secondary outcome
Change in sleep latency time based on sleep actigraph
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Insomnia, run by Lacrima Medical LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse events (time frame: Up to 37 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.