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Insomnia | Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

Insomnia research study

What is the primary objective of this study?

The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.

Who is eligible to participate?

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 Exclusion Criteria for \"Healthy\" control subjects: 1. 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; or - Waking up before 5:00 AM or after 10:00 AM on a regular basis. This will be objectively assessed by wrist actigraphy measured for a 1-week duration prior to the first study night. 2. A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy. 3. A score greater than or equal to 10 on the Epworth Sleepiness Scale. 4. Takes medication that alters sleep, cognitive function, or both. 5. Has a history of a known neurological or psychiatric problem. 6. Younger than 18 or older than 35 years of age. 7. Known or suspected sleep disorder(s).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Insomnia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DexmedetomidineA dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).

Drug:Zolpidem12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Healthy Control SubjectsThis arm will be comprised of 15 healthy male and female controls.

Insomnia subjectsThis arm will be comprised of 15 male and female subjects with a sleep initiating and maintenance disorder.

Study Status

Active, not recruiting

Start Date: January 2015

Completed Date: August 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Subjective and objective measures of sleep quality

Secondary Outcome: Performance on a Psychomotor Vigilance Test (PVT) after waking up from sleep

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Massachusetts General Hospital

Collaborator: National Institutes of Health (NIH)

More information:https://clinicaltrials.gov/show/NCT01485393

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