Clinical trial NCT02818569: Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic
Official title: Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sleep
Insomnia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will receive both the oral dexmedetomidine intervention and placebo comparator in a randomized order.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age between 18-50
* Native English speaking
* ASA physical status classification P1 and P2 (stable chronic condition)
* Normal body habitus.

Exclusion Criteria:

* Abnormal sleep habits
* Sleeping less than 5 hours each night
* Going to sleep before 9:00 PM or after 2:00 AM on a regular basis
* Waking up before 5:00 AM or after 10:00 AM on a regular basis.
* 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 50 years of age.
* Known or suspected sleep disorder(s).

Primary outcomes:
measure: Hemodynamic Stability (Phase I)
timeFrame: Active study night, visit 3 or 4
measure: Polysomnography Sleep Quality (Phase II).
timeFrame: Active study night, visit 3 or 4
Secondary outcomes:
measure: Performance on the Psychomotor Vigilance Task (Phase II)
timeFrame: Active study night, visit 3 or 4
measure: Performance on the Motor Sequence Task (Phase II)
timeFrame: Active study night, visit 3 or 4
measure: Subjective Sleep Quality (Phase II)
timeFrame: Active study night, visit 3 or 4
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: