Overview

This trial is active, not recruiting.

Condition insomnia
Treatments dexmedetomidine, zolpidem
Sponsor Massachusetts General Hospital
Collaborator National Institutes of Health (NIH)
Start date January 2015
End date January 2017
Trial size 30 participants
Trial identifier NCT01485393, 2011P-000715, DP1OD003646

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
This arm will be comprised of 15 healthy male and female controls.
dexmedetomidine
A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).
zolpidem
12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
(Experimental)
This arm will be comprised of 15 male and female subjects with a sleep initiating and maintenance disorder.
dexmedetomidine
A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).
zolpidem
12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).

Primary Outcomes

Measure
Subjective and objective measures of sleep quality
time frame: approximately 8 hours

Secondary Outcomes

Measure
Performance on a word-pair cognitive task after waking up from sleep
time frame: within 1-2hrs after waking up

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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).

Additional Information

Official title Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.