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The broad objective of this investigation is to assess the safety and efficacy of oral therapy with dexmedetomidine for the induction and maintenance of restful sleep.
Sleep is a basic human function that occupies approximately one-third of our lives. Much of what is known about the benefits of sleep in humans has been obtained from studies of patients with insomnia, the most common sleep disorder with a reported prevalence of 10 to 15%. Unfortunately, insomnia is an independent risk factor for acute myocardial infarction, coronary heart disease, heart failure, hypertension, diabetes, and death. More so, sleep disturbances lead to neurocognitive deficits such as delirium and psychosis. However, the principal medications (i.e. benzodiazepines, zolpidem) currently used to treat insomnia are associated with side effects such as daytime sedation, delirium, anterograde memory disturbance, and complex sleep-related behaviors. We recently found that a nighttime intravenous bolus administration of dexmedetomidine was associated with normal sleep architecture comprising of rapid eye movement (REM) and non-REM (N1, N2, N3) sleep, with improved next-day psychomotor vigilance performance compared to zolpidem. Presently, dexmedetomidine is only available in an intravenous formulation. The goal of this project is to develop dexmedetomidine, an alpha-2 receptor agonist, into an oral sleep therapeutic with a neurocognitive sparing profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Dexmedetomidine, Then Placebo | Experimental | This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator. |
|
| Placebo, Then Oral Dexmedetomidine | Experimental | This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Oral form |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic Stability (Phase I) | Number of participants with (1) systolic blood pressure (SBP) < 60 mmHg, diastolic blood pressure (DBP) < 40 mmHg or decrease of SBP by ≥ 50 % from the baseline which is sustained over two consecutive minutes, (2) hypertension: SBP > 180 mmHg, DBP > 100 mmHg, or increase of SBP by ≥ 50 % from the baseline which is sustained over two minutes and, (3) bradycardia: heart rate (HR) < 40 bpm or decrease by ≥ 50 % from the baseline sustained over two consecutive minutes. | Active study night, visit 3 or 4 |
| Polysomnography Sleep Quality (Phase II). | Number of participants who had EEG features of natural sleep. Relative quantities of spindles and k-complexes were used to assess approximation to natural sleep. | Active study night, visit 3 or 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Performance on the Psychomotor Vigilance Task (Phase II) | The number of responses that were longer than 400 milliseconds (lapse 400). | Active study night, visit 3 or 4 |
| Performance on the Motor Sequence Task (Phase II) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
We are undecided.
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All 15 participants completed both arms (dexmedetomidine and placebo) for the study. After being randomized and completing the first arm, patients completed the alternative arm thereafter.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Dexmedetomidine, Then Placebo | This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator. |
| FG001 | Placebo, Then Oral Dexmedetomidine | This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants who were either randomized to receive either Oral Dexmedetomidine or the placebo comparator initially. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter. |
| 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 | Hemodynamic Stability (Phase I) | Number of participants with (1) systolic blood pressure (SBP) < 60 mmHg, diastolic blood pressure (DBP) < 40 mmHg or decrease of SBP by ≥ 50 % from the baseline which is sustained over two consecutive minutes, (2) hypertension: SBP > 180 mmHg, DBP > 100 mmHg, or increase of SBP by ≥ 50 % from the baseline which is sustained over two minutes and, (3) bradycardia: heart rate (HR) < 40 bpm or decrease by ≥ 50 % from the baseline sustained over two consecutive minutes. | Posted | Count of Participants | Participants | Active study night, visit 3 or 4 |
|
Length of study conduction through visits 1-4
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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 | Experimental | Oral Dexmedetomidine Dexmedetomidine: Oral form | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Oluwaseun Johnson-Akeju | Massachusetts General Hospital | 617-724-7200 | 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 | Jul 12, 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 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Patients will receive both the oral dexmedetomidine intervention and placebo comparator in a randomized order.
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| Saline Placebo | Other | Saline Placebo |
|
|
Number of participants with improved MST score after sleeping.
| Active study night, visit 3 or 4 |
| Subjective Sleep Quality (Phase II) | Self-reported sleep latency. | Active study night, visit 3 or 4 |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter. | Count of Participants | Participants |
|
| Race (NIH/OMB) | All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Polysomnography Sleep Quality (Phase II). | Number of participants who had EEG features of natural sleep. Relative quantities of spindles and k-complexes were used to assess approximation to natural sleep. | All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter. | Posted | Number | participants | Active study night, visit 3 or 4 |
|
|
|
| Secondary | Performance on the Psychomotor Vigilance Task (Phase II) | The number of responses that were longer than 400 milliseconds (lapse 400). | Posted | Mean | Standard Deviation | lapses | Active study night, visit 3 or 4 |
|
|
|
| Secondary | Performance on the Motor Sequence Task (Phase II) | Number of participants with improved MST score after sleeping. | Posted | Count of Participants | Participants | Active study night, visit 3 or 4 |
|
|
|
| Secondary | Subjective Sleep Quality (Phase II) | Self-reported sleep latency. | Posted | Mean | Standard Deviation | minutes | Active study night, visit 3 or 4 |
|
|
|
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo Comparator | Saline Saline Placebo: Saline Placebo | 0 | 15 | 0 | 15 | 0 | 15 |
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| D001523 |
| Mental Disorders |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |