Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic

Mass General Brigham

Status and phase: Completed; Phase 2; Phase 1

Conditions: Insomnia; Sleep

Treatments: Drug: Dexmedetomidine; Other: Saline Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02818569

2016P000269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 2 patient groups

Oral Dexmedetomidine, Then Placebo

Experimental group

Description:

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.

Treatment:

Other: Saline Placebo

Drug: Dexmedetomidine

Placebo, Then Oral Dexmedetomidine

Experimental group

Description:

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 .

Treatment:

Other: Saline Placebo

Drug: Dexmedetomidine