Insomnia
Conditions
Brief summary
The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.
Interventions
DRUGDexmedetomidine
A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).
DRUGZolpidem
12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
Sponsors
National Institutes of Health (NIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Patients will receive both interventions in a randomized order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Primary Inclusion Criteria for Insomniac subjects: Subjects will be deemed Insomniacs if they suffer from any of the following: 1. Subject will be required to meet the criteria for insomnia, set by the International Classification of Sleep Disorders, which requires that a patient have difficulty initiating or maintaining sleep that is not accounted for by another sleep disorder, neurologic or psychiatric disorder or substance or medication. 2. Subject will be required to not be on any current pharmacological sleep disorder treatment. 3. Between the ages of 18 and 35 years. 4. Not taking any prescription medications that alter sleep, cognitive functions, or both.
Exclusion criteria
Primary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality | Approximately 8 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep | Approximately 30 minutes after waking up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants who were either randomized to receive either Dexmedetomidine or Zolpidem initially. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Age, Continuous | 23.9 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Approximately 8 hours
Population: All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zolpidem-Induced Sleep | Change in Sleep Quality | Changes in total non-REM sleep | 33.2 minutes |
| Zolpidem-Induced Sleep | Change in Sleep Quality | Changes in N3 sleep | 35.8 minutes |
| Zolpidem-Induced Sleep | Change in Sleep Quality | Subjective differences in sleep | 0 minutes |
| Zolpidem-Induced Sleep | Change in Sleep Quality | Changes in REM sleep | -35 minutes |
| Dexmedetomidine-Induced Sleep | Change in Sleep Quality | Subjective differences in sleep | 0 minutes |
| Dexmedetomidine-Induced Sleep | Change in Sleep Quality | Changes in total non-REM sleep | 0 minutes |
| Dexmedetomidine-Induced Sleep | Change in Sleep Quality | Changes in REM sleep | 0 minutes |
| Dexmedetomidine-Induced Sleep | Change in Sleep Quality | Changes in N3 sleep | 26.8 minutes |
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.
Time frame: Approximately 30 minutes after waking up
Population: All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zolpidem-Induced Sleep | Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep | 26 responses |
| Dexmedetomidine-Induced Sleep | Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep | 12 responses |