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

NCT01485393 | Completed Results

• 2 other identifiers: 2011P-000715DP1OD003646
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Approximately 30 minutes after waking up

Study Arms (2)

Healthy Control Subjects: Zolpidem, Then Dexmedetomidine

EXPERIMENTAL

This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep.

Drug: Dexmedetomidine; Drug: Zolpidem

Healthy Control Subjects: Dexmedetomidine, Then Zolpidem

EXPERIMENTAL

This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep.

Drug: Dexmedetomidine; Drug: Zolpidem

Interventions

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).

Also known as: Precedex

Healthy Control Subjects: Dexmedetomidine, Then Zolpidem; Healthy Control Subjects: Zolpidem, Then Dexmedetomidine

Zolpidem DRUG

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

Healthy Control Subjects: Dexmedetomidine, Then Zolpidem; Healthy Control Subjects: Zolpidem, Then Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine; Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines

Limitations and Caveats

Insomniac patients were not conducted as originally proposed due to difficult enrollment. The Motor Sequence Task was not performed as originally proposed, so it has been removed as a secondary outcome measure.

Results Point of Contact

• Title: Dr. Johnson-Akeju
• Organization: MGH

ojohnsonakeju@partners.org

6177247200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Anesthaesia

Model Details: Patients will receive both interventions in a randomized order.

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 5, 2011
• Study Start: January 1, 2015
• Primary Completion: January 29, 2018
• Study Completion: June 29, 2018
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-10

Locations

US (1)