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

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ClinicalTrials.gov Identifier: NCT01485393
Recruitment Status : Completed
First Posted : December 5, 2011
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Insomnia
Interventions Drug: Dexmedetomidine
Drug: Zolpidem
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Control Subjects: Zolpidem, Then Dexmedetomidine Healthy Control Subjects: Dexmedetomidine, Then Zolpidem
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants who were either randomized to receive either Dexmedetomidine or Zolpidem initially.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
23.9
(21 to 29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Change in Sleep Quality
Hide Description 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.
Time Frame Approximately 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.
Arm/Group Title Zolpidem-Induced Sleep Dexmedetomidine-Induced Sleep
Hide Arm/Group Description:
All healthy control subjects undergo a night of zolpidem-induced sleep.
All healthy control subjects undergo a night of dexmedetomidine-induced sleep.
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: minutes
Changes in total non-REM sleep
33.2
(4.6 to 61.7)
0
(0 to 0)
Changes in REM sleep
-35
(-60.3 to -9.8)
0
(0 to 0)
Changes in N3 sleep
35.8
(2.7 to 68.9)
26.8
(2.2 to 51.3)
Subjective differences in sleep
0
(0 to 0)
0
(0 to 0)
2.Secondary Outcome
Title Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep
Hide Description 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.
Time Frame Approximately 30 minutes after waking up
Hide Outcome Measure Data
Hide Analysis Population Description
All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.
Arm/Group Title Zolpidem-Induced Sleep Dexmedetomidine-Induced Sleep
Hide Arm/Group Description:
All healthy control subjects undergo a night of zolpidem-induced sleep.
All healthy control subjects undergo a night of Dexmedetomidine-induced sleep.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: responses
26 12
Time Frame Through completion of all three study visits (approximately 2 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem Dexmedetomidine
Hide Arm/Group Description This arm reflects the night of Zolpidem-induced sleep for all 10 participants. This arm reflects the night of Dexmedetomidine-induced sleep for all 10 participants.
All-Cause Mortality
Zolpidem Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 

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.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Johnson-Akeju
Organization: MGH
Phone: 6177247200
EMail: ojohnsonakeju@partners.org
Layout table for additonal information
Responsible Party: Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01485393     History of Changes
Other Study ID Numbers: 2011P-000715
DP1OD003646 ( U.S. NIH Grant/Contract )
First Submitted: November 30, 2011
First Posted: December 5, 2011
Results First Submitted: January 4, 2019
Results First Posted: October 8, 2019
Last Update Posted: October 8, 2019