Trial Outcomes & Findings for Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep (NCT NCT01485393)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Approximately 8 hours

Results posted on

2019-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Control Subjects: Zolpidem, Then Dexmedetomidine 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.	Healthy Control Subjects: Dexmedetomidine, Then Zolpidem 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.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=10 Participants All study participants who were either randomized to receive either Dexmedetomidine or Zolpidem initially.
Age, Continuous	23.9 years n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Approximately 8 hours

Population: All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.

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.

Outcome measures

Outcome measures
Measure	Zolpidem-Induced Sleep n=10 Participants All healthy control subjects undergo a night of zolpidem-induced sleep.	Dexmedetomidine-Induced Sleep n=10 Participants All healthy control subjects undergo a night of dexmedetomidine-induced sleep.
Change in Sleep Quality Changes in total non-REM sleep	33.2 minutes Interval 4.6 to 61.7	0 minutes Interval 0.0 to 0.0
Change in Sleep Quality Changes in REM sleep	-35 minutes Interval -60.3 to -9.8	0 minutes Interval 0.0 to 0.0
Change in Sleep Quality Changes in N3 sleep	35.8 minutes Interval 2.7 to 68.9	26.8 minutes Interval 2.2 to 51.3
Change in Sleep Quality Subjective differences in sleep	0 minutes Interval 0.0 to 0.0	0 minutes Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Approximately 30 minutes after waking up

Population: All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.

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.

Outcome measures

Outcome measures
Measure	Zolpidem-Induced Sleep n=10 Participants All healthy control subjects undergo a night of zolpidem-induced sleep.	Dexmedetomidine-Induced Sleep n=10 Participants All healthy control subjects undergo a night of dexmedetomidine-induced sleep.
Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep	26 responses	12 responses

Adverse Events

Zolpidem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Johnson-Akeju

MGH

Phone: 6177247200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place