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| ID | Type | Description | Link |
|---|---|---|---|
| DP1OD003646 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control Subjects: Zolpidem, Then Dexmedetomidine | Experimental | This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep. |
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| Healthy Control Subjects: Dexmedetomidine, Then Zolpidem | Experimental | This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Quality | Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep--all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity. | Approximately 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep | The PVT is a measure of reaction time. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds. | Approximately 30 minutes after waking up |
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Inclusion Criteria:
Subjects will be deemed "Insomniacs" if they suffer from any of the following:
Exclusion Criteria:
Primary Exclusion Criteria for "Healthy" control subjects:
Abnormal sleep habits:
A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy.
A score greater than or equal to 10 on the Epworth Sleepiness Scale.
Takes medication that alters sleep, cognitive function, or both.
Has a history of a known neurological or psychiatric problem.
Younger than 18 or older than 35 years of age.
Known or suspected sleep disorder(s).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Control Subjects: Zolpidem, Then Dexmedetomidine | This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep. |
| FG001 | Healthy Control Subjects: Dexmedetomidine, Then Zolpidem | This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants who were either randomized to receive either Dexmedetomidine or Zolpidem initially. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Sleep Quality | Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep--all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity. | All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order. | Posted | Median | Inter-Quartile Range | minutes | Approximately 8 hours |
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Through completion of all three study visits (approximately 2 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zolpidem | This arm reflects the night of Zolpidem-induced sleep for all 10 participants. |
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Insomniac patients were not conducted as originally proposed due to difficult enrollment.
The Motor Sequence Task was not performed as originally proposed, so it has been removed as a secondary outcome measure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Johnson-Akeju | MGH | 6177247200 | ojohnsonakeju@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2017 | Aug 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Patients will receive both interventions in a randomized order.
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| Zolpidem | Drug | 12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently). |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Dexmedetomidine-Induced Sleep |
All healthy control subjects undergo a night of dexmedetomidine-induced sleep. |
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| Secondary | Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep | The PVT is a measure of reaction time. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds. | All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order. | Posted | Number | responses | Approximately 30 minutes after waking up |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Dexmedetomidine | This arm reflects the night of Dexmedetomidine-induced sleep for all 10 participants. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D001523 |
| Mental Disorders |
| D011725 |
| Pyridines |