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Completed

NCT Number: NCT01485393

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary Inclusion Criteria for "Insomniac" subjects:

Subjects will be deemed "Insomniacs" if they suffer from any of the following:

  • 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.
  • Subject will be required to not be on any current pharmacological sleep disorder treatment.
  • Between the ages of 18 and 35 years.
  • Not taking any prescription medications that alter sleep, cognitive functions, or both.

Exclusion criteria

Primary Exclusion Criteria for "Healthy" control subjects:

  • 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.
  • A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy.
  • A score greater than or equal to 10 on the Epworth Sleepiness Scale.
  • 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 35 years of age.
  • Known or suspected sleep disorder(s).

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

zolpidem

Drug

12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).

Primary outcomes

  1. Change in Sleep Quality

    Time frame: 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 outcomes

  1. Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2011
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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