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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485393
• Other study ID #: 2011P-000715
• Secondary ID: DP1OD003646
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 29, 2018

Study information

• Verified date: October 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 29, 2018
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep Quality	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.	Approximately 8 hours
Secondary	Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep	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.	Approximately 30 minutes after waking up