InsomniaNCT01485393

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

A study testing Dexmedetomidine and Zolpidem in people with Insomnia, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Insomnia
What is being tested?: Dexmedetomidine and Zolpidem
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Jan 2015to 29 Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Pilot 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.

Conditions: Insomnia
Being tested: Dexmedetomidine, Zolpidem
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called Precedex
A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).
ZolpidemDrug
12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).

Study groups in NCT01485393
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Dexmedetomidine; Drug: Zolpidem

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Approximately 8 hours

Secondary outcomes (1)

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.
Measured: Approximately 30 minutes after waking up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201529 Jun 2018

First posted5 Dec 2011 (estimated)
Study startJan 2015
Primary completion29 Jan 2018
Study completion29 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Patients will receive both interventions in a randomized order.
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01485393
Sponsor's protocol ID: 2011P-000715
Other IDs: DP1OD003646
Status last verified: Oct 2019
First submitted: 30 Nov 2011
Last updated: 8 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder

All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
ClinicalTrials.gov ID: NCT01485393
Acronym / sponsor ID: 2011P-000715
Conditions: Insomnia
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: Jan 2015
Primary completion: 29 Jan 2018 (actual)
Study completion: 29 Jun 2018 (actual)
First posted: 5 Dec 2011 (estimated)
Results: Posted 8 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Patients will receive both interventions in a randomized order.

Arm	Type	Receives
Healthy Control Subjects: Zolpidem, Then Dexmedetomidine	Experimental	Drug: Dexmedetomidine, Drug: ZolpidemThis 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	Experimental	Drug: Dexmedetomidine, Drug: ZolpidemThis 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.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Primary Inclusion Criteria for "Insomniac" subjects:
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.

Key exclusion criteria (11 listed)

Abnormal sleep habits:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexmedetomidineAlso: PrecedexA dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).	Drug	Healthy Control Subjects: Dexmedetomidine, Then Zolpidem, Healthy Control Subjects: Zolpidem, Then Dexmedetomidine
Zolpidem12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).	Drug	Healthy Control Subjects: Dexmedetomidine, Then Zolpidem, Healthy Control Subjects: Zolpidem, Then Dexmedetomidine

Primary outcome

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.

1 secondary outcome

Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep
Time frame: Approximately 30 minutes after waking up

Results and safety

Results posted to the registry on 8 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Control Subjects: Zolpidem, Then Dexmedetomidine	5	5
Healthy Control Subjects: Dexmedetomidine, Then Zolpidem	5	5

Primary outcome: Change in Sleep Quality

Time frame: Approximately 8 hours. Median (Inter-Quartile Range). Unit: minutes

Measure	Zolpidem-Induced Sleep n = 10	Dexmedetomidine-Induced Sleep n = 10
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)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through completion of all three study visits (approximately 2 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zolpidem	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Dexmedetomidine	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Insomnia

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine and Zolpidem in people with Insomnia, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sleep Quality (time frame: Approximately 8 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01485393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.