InsomniaPhase 1NCT01209728
Effects of Insomnia on Simulated Driving (MK-0000-183-00)
A Phase 1 study of Insomnia, run by Merck Sharp & Dohme LLC.
Trial summary
This is a double-blind, parallel design study in elderly primary insomnia patients and demographically matched controls. The objectives if this study are primarily: 1. To determine if functional deficits in simulated driving performance can be demonstrated in primary insomnia patients, and detected in healthy… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2010to 1 Sep 2011
- Phase
- Phase 1
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- A patient may not participate in the study if ANY of the criteria below (among others determined by the study staff) apply.
- The participant:
- Has visual or auditory impairment;
- Has a history of clinically significant endocrine (including diabetes), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases;
- Has a history of neoplastic disease ;
- Is taking, or plans to take, one or more of the following medications (non-inclusive), within the 2 weeks prior to screening and throughout the course of the study: Centrally acting anticholinergics or antihistamines; Melatonin; Anticonvulsants; Antipsychotics; Anxiolytics; Benzodiazepines; Hypnotics; Any CNS depressants; Over-the-counter medications that could affect sleep; Stimulants; Diet pills; Anti-depressants; Disulfiram;
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- Has a positive screening urine drug test (e.g., positive for benzodiazepines, cannabinoids, cocaine, etc.);
- Has a lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder or a psychiatric condition requiring treatment with a prohibited medication; or other current psychiatric condition that, in the investigator's opinion, would interfere with the subject/patient's ability to participate in the study ;
- Has evidence of suicidality;
- Has a history of transmeridian travel (across > 3 time zones or > 3 hour time difference) within two weeks prior to screening or anticipates transmeridian travel during the study;
- Has a history of shift work (defined as permanent night shift or rotating day/night shift work) within the past two weeks prior to screening or anticipates need to perform shift work during the study;
- Has a history or diagnosis of any of following conditions, in the opinion of the investigator: Narcolepsy; Cataplexy (familial or idiopathic); Circadian Rhythm Sleep Disorder; Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and REM behavior disorder; Sleep-related Breathing Disorder (obstructive or central sleep apnea syndrome, central alveolar hypoventilation syndrome); Periodic Limb Movement Disorder; Restless Legs Syndrome; Primary Hypersomia; Excessive Daytime Sleepiness (EDS), not attributable to Primary Insomnia
- Has a recent and/or active history of a confounding neurological disorder, including but not limited to: seizure disorder, stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or significant head trauma with sustained loss of consciousness and residual impairment within the last 10 years;
- Has a history of allergy, exceptional sensitivity, or adverse reaction to alcohol;
- Has a significant history of motion sickness or demonstrates significant simulator sickness during practice drives at screening;
- Consumes excessive amounts of alcohol or subject or patient consumes alcohol to promote sleep (i.e., within 3 hours before going to bed);
- Has never consumed alcohol;
- Consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages.
About this study
Official title: A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs
This is a double-blind, parallel design study in elderly primary insomnia patients and demographically matched controls. The objectives if this study are primarily: 1. To determine if functional deficits in simulated driving performance can be demonstrated in primary insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily: 2. To compare simulated driving performance deficits in elderly primary insomnia patients to those in healthy elderly volunteers impaired by alcohol, for at least one of the following driving endpoints: standard deviation of lane position (SDLP), standard deviation of speed (speed deviation), lane excursions, and a driving composite score.
- Conditions
- Insomnia
- Being tested
- Placebo/ethanol (blinded)
- Keywords
- insomnia, insomniacs, simulated driving, alcohol, ethanol
- 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.
Placebo/ethanol (blinded)Other
Also called Placebo or ethanol (blinded)
Elderly participants, including primary insomnia patients and healthy subjects will be administered i.v. ethanol or placebo in a blinded manner
| Study group | Role | What they receive |
|---|---|---|
| Primary insomnia patients and healthy subjects | Experimental | Elderly participants, including primary insomnia patients and healthy subjects Receives: Other: Placebo/ethanol (blinded) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulated driving variables
Simulated driving variables which may include (standard deviation of lane position (SDLP), speed deviation, lane excursions, or a composite score of several driving variables).
Measured: Evaluated on, up to, 3 different days, with 2 driving sessions of ~65 minutes each day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study start1 Oct 2010
- Primary completion1 Sep 2011
- Study completion1 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209728
- Sponsor's protocol ID
- 0000-183
- Status last verified
- Jun 2019
- First submitted
- 24 Sep 2010
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Simen AA, Gargano C, Cha JH, Drexel M, Bautmans A, Heirman I, Laethem T, Hochadel T, Gheyle L, Bleys K, Beals C, Stoch A, Kay GG, Struyk A. A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone. Ther Adv Drug Saf. 2015 Jun;6(3):86-97. doi: 10.1177/2042098615579314.
PubMed 26240742
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs
- ClinicalTrials.gov ID
- NCT01209728
- Acronym / sponsor ID
- 0000-183
- Conditions
- Insomnia
- Keywords
- insomnia, insomniacs, simulated driving, alcohol, ethanol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2010 (actual)
- Primary completion
- 1 Sep 2011 (actual)
- Study completion
- 1 Sep 2011 (actual)
- First posted
- 27 Sep 2010 (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.
This is a double-blind, parallel design study in elderly primary insomnia patients and demographically matched controls. The objectives if this study are primarily: 1. To determine if functional deficits in simulated driving performance can be demonstrated in primary insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily: 2. To compare simulated driving performance deficits in elderly primary insomnia patients to those in healthy elderly volunteers impaired by alcohol, for at least one of the following driving endpoints: standard deviation of lane position (SDLP), standard deviation of speed (speed deviation), lane excursions, and a driving composite score.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary insomnia patients and healthy subjects | Experimental | Other: Placebo/ethanol (blinded)Elderly participants, including primary insomnia patients and healthy subjects |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- A patient may not participate in the study if ANY of the criteria below (among others determined by the study staff) apply.
- Has visual or auditory impairment;
- Has a history of clinically significant endocrine (including diabetes), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases;
- Has a history of neoplastic disease ;
- Is taking, or plans to take, one or more of the following medications (non-inclusive), within the 2 weeks prior to screening and throughout the course of the study: Centrally acting anticholinergics or antihistamines; Melatonin; Anticonvulsants; Antipsychotics; Anxiolytics; Benzodiazepines; Hypnotics; Any CNS depressants; Over-the-counter medications that could affect sleep; Stimulants; Diet pills; Anti-depressants; Disulfiram;
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 |
|---|---|---|
| Placebo/ethanol (blinded)Also: Placebo or ethanol (blinded)Elderly participants, including primary insomnia patients and healthy subjects will be administered i.v. ethanol or placebo in a blinded manner | Other | Primary insomnia patients and healthy subjects |
Primary outcome
Simulated driving variables
Time frame: Evaluated on, up to, 3 different days, with 2 driving sessions of ~65 minutes each day.
Simulated driving variables which may include (standard deviation of lane position (SDLP), speed deviation, lane excursions, or a composite score of several driving variables).
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 12 Jun 2019.
- Results publication: PubMed 26240742Simen AA, Gargano C, Cha JH, Drexel M, Bautmans A, Heirman I, Laethem T, Hochadel T, Gheyle L, Bleys K, Beals C, Stoch A, Kay GG, Struyk A. A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone. Ther Adv Drug Saf. 2015 Jun;6(3):86-97. doi: 10.1177/2042098615579314.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Insomnia, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 18 exclusion criteria. 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Simulated driving variables (time frame: Evaluated on, up to, 3 different days, with 2 driving sessions of ~65 minutes each day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01209728, which also lists 1 linked publication.
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 12 Jun 2019.